Dietary Treatment of Crohn's Disease

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00343642
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 73
• Locations: 2
• Arms: 3
• Duration (Months): 73
• Patients Per Site: 36.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Our objective is to determine whether a specific dietary intervention or a fructooligosaccharide (FOS) supplement has anti-oxidant or prebiotic effects and whether it is beneficial in the treatment of Crohn's Disease (CD.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease; Inflammatory Bowel Disease	Drug: Active fructo-oligosaccharide; Drug: Placebo fructo-oligosaccharide; Dietary Supplement: Diet	Phase 1/Phase 2

Detailed Description

Several epidemiological studies and therapeutic observations in the complementary and alternative medicine (CAM) literature suggest that diet is key to development of CD and its treatment. The investigators took advantage of these CAM recommendations and designed dietary interventions. Our preliminary open label studies in IBD patients showed that our interventions are acceptable and well-tolerated and result in improvement, reducing symptoms and/or the degree of inflammation. The investigators are now seeking to validate this finding and determine the mechanisms underlying the effects of dietary manipulation-such as potential effects on colonic bacterial microflora. In another pilot study using 16s rDNA bacterial fingerprinting, the investigators demonstrated that the intestinal microflora of patients with CD differ significantly from healthy individuals. Whether the investigators can normalize/change the microflora of CD patients with dietary therapies, however, remains to be determined. Accordingly, the investigators designed a double blind placebo controlled study to test the hypotheses that: (1) dietary manipulation with either diet or a FOS supplement is an effective CAM therapy that prevents CD relapse (leads to maintenance of remission) and (2) such dietary manipulation can normalize the microflora of CD patients and decrease mucosal oxidative damage.

90 participants are expected to undergo the trial and have a 2:1 chance of receiving active therapy. The trial is seeking to enroll participants with inactive CD who have been medically induced into remission within 9 months of enrollment. Participants must be on their Crohn's medications at a stable dose for 3 months, which does not include steroids (e.g. Prednisone, Entocort) or antibiotics at the time of enrollment. Participants will be followed till relapse occurs or up to 52 weeks. Participants are asked to fill out a variety of questionnaires, keep a food and adverse event diary, and have a research, limited, unprepped flexible sigmoidoscopy for colonic tissue collection at the beginning and end of the study period.

Significance. This study could provide information to suggest diet or dietary supplement as a safe therapy for IBD and lay the groundwork for more definitive, randomized, controlled trials.

Study Design

• Study Type: Interventional
• Actual Enrollment: 73 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Dietary Treatment of Crohn's Disease
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active Fructo-oligosaccharide Subjects received an active fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans. The fructo-oligosaccharide supplement was administered orally in a powder form two teaspoons daily.	Drug: Active fructo-oligosaccharide; 2 teaspoons of active fructo-oligosaccharides daily and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans; Other Names: Active fructooligosaccharide (FOS) and Placebo Diet Time and Attention and Active Fructooligosaccharide
Placebo Comparator: Placebo Fructo-oligosaccharide Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.	Drug: Placebo fructo-oligosaccharide; 2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily) and Time and attention administering usual dietary recommendations for a healthy diet based on 2005 Dietary Guidelines for Americans; Other Names: Placebo Diet and Placebo Supplement Tiem and Attention and Fructooligosaccharide Placebo
Active Comparator: Dietary Therapy Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.	Dietary Supplement: Diet; A restrictive anti-inflammatory diet developed by the research team and 2 teaspoons of placebo fructose powder ( to serve as the placebo equivalent of active treatment with fructo-oligosaccharides daily); Other Names: Active Dietary Intervention and Placebo Supplement Dietary Treatment and Fructooligosaccharide Placebo

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Flare Up of Crohn's Disease Through Month 12 [Up to 12 months]

   The efficacy of the dietary treatment was assessed by looking at the number of participants who flared.

2. Quality of Life in Patients Taking Dietary Treatments [At exit visit of study]

   Inflammatory Bowel Disease Questionnaire (IBDQ) overall scores at the exit visit of the study.It consists of 32 questons divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.

3. Safety of Dietary Treatments [90 days]

   Data not collected

Secondary Outcome Measures

1. Changes in Ileocolonic Flora [90 days]

   Data not collected

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Documented ileocolonic or colonic CD based on classical history and classical endoscopic or surgical findings and histology compatible with CD;

2. Induction of remission with medical therapy within 9 months of the study;

3. Inactive CD for at least 2 weeks with CDAI score less than 150;

4. No change in IBD medication doses for 3 months;

5. No change in smoking habits a month prior to enrollment (because smoking may exacerbate CD) and acceptance of not-changing smoking habits during the term of the study).

Exclusion Criteria:

1. Patients with history of bowel obstruction and/or known strictures (as the high fiber content may precipitate obstruction);

2. Patients with extensive colonic or ileocolonic resection;

3. Patients with ileostomies or colostomies with diverted fecal stream;

4. Patients with isolated perianal/anorectal disease;

5. Patients with surgically induced remission;

6. Concomitant infection (e.g., C. difficile colitis);

7. Use of antibiotics within 4 weeks, or steroids, herbal remedies or diet therapies within 2 weeks of the onset of the trial or during the study;

8. Use of potential IBD exacerbators such as NSAIDs within 1 wk of the study;

9. Acute illness requiring immediate hospitalization for CD or other reasons;

10. Presence of symptomatic organic GI disease other than CD, hemorrhoids, hiatal hernia; GERD;

11. Pre-existent organ failure or severe comorbidities as these may change Gl flora:

• Liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X> normal);

• Kidney disease (creatinine>2.0 mg/dL);

• Uncontrolled psychiatric illness;

• Clinically important lung disease or heart failure;

• HIV disease;

• Alcoholism;

• Transplant recipients;

• Patients receiving other immunosuppressant medications for comorbidities (e.g. Enbrel for rheumatoid arthritis);

1. Presence of short bowel syndrome or severe malnutrition with ideal body weight less than or equal to 90% or predicted;

2. Estimated survival <1 year and Karnofsky performance status <50%;

3. Desire to become pregnant during study or current pregnancy or nursing;

4. Desire to change smoking-status during the study;

5. Daily use of anticoagulation and antiplatelet medications;

6. Complicated IBD with anticipation of imminent surgical intervention during the term of the study;

7. Inability to have a regular follow-up and comply with study requirements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastroenterology Associates of Central Georgia	Macon	Georgia	United States	31201
2	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

• Rush University Medical Center
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Ece A Mutlu, MD MBA, Rush University Medical Center
• Study Director: Ali Keshavarzian, MD, Rush University Medical Center
• Study Director: Shahriar Sedghi, MD, Gastroenterology Associates of Central Georgia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT00343642
• Other Study ID Numbers: R21AT001628-01A2; R21AT001628-01A2
• First Posted: Jun 23, 2006
• Last Update Posted: Jun 9, 2021
• Last Verified: May 1, 2021

• Keywords provided by Rush University Medical Center: Crohn's disease; Fructooligosaccharide; Inulin; Diet; Treatment; Bacterial flora; Oxidative stress
• Additional relevant MeSH terms: Crohn Disease; Inflammatory Bowel Diseases

Study Results

Participant Flow

Recruitment Details	54 subjects were randomized into a 12 month randomized, double blind, placebo controlled trial to test the efficacy of a specialized restrictive diet and a Fructo-oligosaccharide (FOS) supplement in maintenance of remission in patients with Crohn's disease (CD). Participants were recruited at Rush University, Chicago between Sept 2005-2012.

Arm/Group Title	Time and Attention and Active Fructo-oligosaccharide	Time and Attention and Fructo-oligosaccharide Placebo	Dietary Therapy and Fructo-oligosaccharide Placebo
Arm/Group Description	Subjects received an active prebiotic fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans	Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.	Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.
Period Title: Overall Study
STARTED	19	19	16
Upto 3 Months Complete or Flare	2	0	1
3-6 Months Complete or Flare	4	2	2
COMPLETED	10	11	9
NOT COMPLETED	9	8	7

Baseline Characteristics

Arm/Group Title	Time and Attention + Active Fructooligosaccharide Supplement.	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo	Total
Arm/Group Description	Time and attention + active fructooligosaccharide supplement. Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily	Time and attention + fructooligosaccharide placebo Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily	Dietary therapy + fructooligosaccharide placebo dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder	Total of all reporting groups
Overall Participants	19	19	16	54
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	17 89.5%	16 84.2%	14 87.5%	47 87%
>=65 years	2 10.5%	3 15.8%	2 12.5%	7 13%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.21 (12.43)	48 (16.89)	45.13 (14.17)	45.46 (14.51)
Sex: Female, Male (Count of Participants)
Female	10 52.6%	13 68.4%	10 62.5%	33 61.1%
Male	9 47.4%	6 31.6%	6 37.5%	21 38.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	5 26.3%	0 0%	5 9.3%
Not Hispanic or Latino	19 100%	14 73.7%	16 100%	49 90.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	1 5.3%	0 0%	1 1.9%
Black or African American	4 21.1%	2 10.5%	4 25%	10 18.5%
White	15 78.9%	16 84.2%	12 75%	43 79.6%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	19 100%	19 100%	16 100%	54 100%
Smoking (participants) [Number]
Smokers	3 15.8%	1 5.3%	0 0%	4 7.4%
Non-smokers	16 84.2%	18 94.7%	16 100%	50 92.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Flare Up of Crohn's Disease Through Month 12
Description	The efficacy of the dietary treatment was assessed by looking at the number of participants who flared.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Time and Attention + Active Fructooligosaccharide Supplement	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo
Arm/Group Description	Time and attention + active fructooligosaccharide supplement. Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily	Time and attention + fructooligosaccharide placebo Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily	Dietary therapy + fructooligosaccharide placebo dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder
Measure Participants	19	19	16
Number [participants]	6 31.6%	4 21.1%	0 0%

2. Primary Outcome

Title	Quality of Life in Patients Taking Dietary Treatments
Description	Inflammatory Bowel Disease Questionnaire (IBDQ) overall scores at the exit visit of the study.It consists of 32 questons divided into four dimensions: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items) and social function (5 items). Every question has graded responses from 1 (worst situation) to 7 (best situation), and thus the total score is ranging from 32 to 224 with higher scores representing better quality of life.
Time Frame	At exit visit of study

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Time and Attention and Active Fructooligosaccharide Supplement	Time and Attention and Fructo-oligosaccharide Placebo	Dietary Therapy and Fructooligosaccharide Placebo
Arm/Group Description	Subjects received an active prebiotic fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.	Subjects received a placebo fructo-oligosaccharide supplement and a diet following the 2005 Dietary Guidelines for Americans.	Subjects received a placebo fructo-oligosaccharide supplement and a restrictive anti-inflammatory diet developed by the research team.
Measure Participants	19	19	16
Mean (Standard Deviation) [units on a scale]	180.17 (24.78)	197.42 (22.55)	196 (18.52)

3. Primary Outcome

Title	Safety of Dietary Treatments
Description	Data not collected
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

Data not Collected

Arm/Group Title	Time and Attention + Active Fructooligosaccharide Supplement	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo
Arm/Group Description	Time and attention + active fructooligosaccharide supplement. Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily	Time and attention + fructooligosaccharide placebo Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily	Dietary therapy + fructooligosaccharide placebo dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder
Measure Participants	0	0	0

4. Secondary Outcome

Title	Changes in Ileocolonic Flora
Description	Data not collected
Time Frame	90 days

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	Time and Attention + Active Fructooligosaccharide Supplement	Time and Attention + Fructooligosaccharide Placebo	Dietary Therapy + Fructooligosaccharide Placebo
Arm/Group Description	Time and attention + active fructooligosaccharide supplement. Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily	Time and attention + fructooligosaccharide placebo Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily	Dietary therapy + fructooligosaccharide placebo dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder
Measure Participants	0	0	0

Adverse Events

Time Frame	1 year
Arm/Group Title	Time and Attention + Active Fructooligosaccharide Supplement.		Time and Attention + Fructooligosaccharide Placebo		Dietary Therapy + Fructooligosaccharide Placebo
Arm/Group Description	Time and attention + active fructooligosaccharide supplement. Time and attention + active fructooligosaccharide supplementation: 2 teaspoons of fructooligosaccharides daily		Time and attention + fructooligosaccharide placebo Time and attention + fructo-oligosaccharide placebo: 2 teaspoons of placebo powder daily		Dietary therapy + fructooligosaccharide placebo dietary therapy + fructo-oligosaccharide placebo: Medical nutrition therapy and 2 teaspoons of placebo powder
All Cause Mortality
	Time and Attention + Active Fructooligosaccharide Supplement.		Time and Attention + Fructooligosaccharide Placebo		Dietary Therapy + Fructooligosaccharide Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Time and Attention + Active Fructooligosaccharide Supplement.		Time and Attention + Fructooligosaccharide Placebo		Dietary Therapy + Fructooligosaccharide Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/19 (10.5%)		1/19 (5.3%)		0/16 (0%)
Gastrointestinal disorders
Crohn's flare up	1/19 (5.3%)	1	0/19 (0%)	0	0/16 (0%)	0
Nervous system disorders
Syncope	1/19 (5.3%)	1	0/19 (0%)	0	0/16 (0%)	0
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection	0/19 (0%)	0	1/19 (5.3%)	1	0/16 (0%)	0
Other (Not Including Serious) Adverse Events
	Time and Attention + Active Fructooligosaccharide Supplement.		Time and Attention + Fructooligosaccharide Placebo		Dietary Therapy + Fructooligosaccharide Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/19 (100%)		19/19 (100%)		16/16 (100%)
Cardiac disorders
Cardio vascular and Pulmonary symptoms	11/19 (57.9%)	13	9/19 (47.4%)	11	8/16 (50%)	14
Abnormal Heart exam	0/19 (0%)	0	1/19 (5.3%)	1	3/16 (18.8%)	4
Hypertension	1/19 (5.3%)	1	1/19 (5.3%)	1	1/16 (6.3%)	1
Ear and labyrinth disorders
Abnormal ear exam	3/19 (15.8%)	4	0/19 (0%)	0	1/16 (6.3%)	1
Endocrine disorders
Endocrine signs and symptoms	0/19 (0%)	0	3/19 (15.8%)	4	2/16 (12.5%)	2
Eye disorders
Eye symptoms	0/19 (0%)	0	1/19 (5.3%)	2	3/16 (18.8%)	4
Gastrointestinal disorders
Infection- GI	0/19 (0%)	0	0/19 (0%)	0	2/16 (12.5%)	3
Constipation	1/19 (5.3%)	1	5/19 (26.3%)	10	2/16 (12.5%)	2
Abnormal abdominal exam	8/19 (42.1%)	19	9/19 (47.4%)	20	4/16 (25%)	9
GERD symptoms	5/19 (26.3%)	6	6/19 (31.6%)	8	0/16 (0%)	0
Diarrhea/Frequent BM	10/19 (52.6%)	14	6/19 (31.6%)	9	7/16 (43.8%)	8
Perianal and Rectal pain/discomfort	0/19 (0%)	0	4/19 (21.1%)	7	2/16 (12.5%)	2
Abdominal discomfort+pain	13/19 (68.4%)	57	13/19 (68.4%)	34	11/16 (68.8%)	37
Decrease in Appetite	1/19 (5.3%)	1	0/19 (0%)	0	0/16 (0%)	0
Gas/Flatus	7/19 (36.8%)	14	8/19 (42.1%)	11	5/16 (31.3%)	7
Rectal Bleeding	3/19 (15.8%)	4	1/19 (5.3%)	2	0/16 (0%)	0
Change in bowel habits	2/19 (10.5%)	3	2/19 (10.5%)	2	0/16 (0%)	0
Urgency - Bowel	1/19 (5.3%)	1	1/19 (5.3%)	1	3/16 (18.8%)	3
Tenesmus	1/19 (5.3%)	1	1/19 (5.3%)	1	0/16 (0%)	0
Hernia - abdominal	1/19 (5.3%)	1	0/19 (0%)	0	0/16 (0%)	0
Hemorrhoids	1/19 (5.3%)	1	1/19 (5.3%)	1	1/16 (6.3%)	1
General disorders
Tooth issues	0/19 (0%)	0	1/19 (5.3%)	1	1/16 (6.3%)	1
Fever	6/19 (31.6%)	8	4/19 (21.1%)	4	3/16 (18.8%)	4
Nausea/Vomitting	9/19 (47.4%)	16	4/19 (21.1%)	4	4/16 (25%)	4
Extraintestinal Symptoms of IBD other than arthritis /arthralgia	1/19 (5.3%)	1	3/19 (15.8%)	5	4/16 (25%)	6
Fatigue	10/19 (52.6%)	13	4/19 (21.1%)	9	2/16 (12.5%)	3
Weight Decline	0/19 (0%)	0	1/19 (5.3%)	2	1/16 (6.3%)	1
Weight Gain	1/19 (5.3%)	1	0/19 (0%)	0	0/16 (0%)	0
Hepatobiliary disorders
Portal Hypertension	0/19 (0%)	0	1/19 (5.3%)	1	0/16 (0%)	0
Immune system disorders
Allergy symptoms	3/19 (15.8%)	6	5/19 (26.3%)	6	4/16 (25%)	8
Infections and infestations
Infection-Lip Herpes	2/19 (10.5%)	2	0/19 (0%)	0	0/16 (0%)	0
Infection- HPV	0/19 (0%)	0	1/19 (5.3%)	1	0/16 (0%)	0
Infection- Cellulitis	0/19 (0%)	0	1/19 (5.3%)	1	0/16 (0%)	0
Infection- Shingles	1/19 (5.3%)	1	1/19 (5.3%)	1	1/16 (6.3%)	1
Infection- Genital	1/19 (5.3%)	1	0/19 (0%)	0	0/16 (0%)	0
Abscess	0/19 (0%)	0	1/19 (5.3%)	1	1/16 (6.3%)	1
Musculoskeletal and connective tissue disorders
Fractures	0/19 (0%)	0	2/19 (10.5%)	2	0/16 (0%)	0
Joint pain/ MSK problems	12/19 (63.2%)	31	7/19 (36.8%)	29	9/16 (56.3%)	21
Polymyalgia rheumatica	0/19 (0%)	0	1/19 (5.3%)	1	0/16 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell skin cancer	1/19 (5.3%)	1	0/19 (0%)	0	0/16 (0%)	0
Nervous system disorders
Neurological symptoms	12/19 (63.2%)	18	12/19 (63.2%)	17	6/16 (37.5%)	6
Psychiatric disorders
Psychiatric symptoms	4/19 (21.1%)	4	7/19 (36.8%)	9	4/16 (25%)	6
Renal and urinary disorders
GenitoUrinary symptoms	3/19 (15.8%)	8	3/19 (15.8%)	8	4/16 (25%)	4
Abnormal exam due to URI	5/19 (26.3%)	6	7/19 (36.8%)	9	0/16 (0%)	0
Infection- URI	13/19 (68.4%)	31	9/19 (47.4%)	15	9/16 (56.3%)	20
Infection-UTI	0/19 (0%)	0	1/19 (5.3%)	3	1/16 (6.3%)	1
Kidney Stone	0/19 (0%)	0	1/19 (5.3%)	1	0/16 (0%)	0
Skin and subcutaneous tissue disorders
Dry skin	5/19 (26.3%)	6	2/19 (10.5%)	3	1/16 (6.3%)	1
Skin lesions	10/19 (52.6%)	14	7/19 (36.8%)	11	7/16 (43.8%)	10
Folliculitis	1/19 (5.3%)	1	0/19 (0%)	0	0/16 (0%)	0
Surgical and medical procedures
Surgeries	0/19 (0%)	0	3/19 (15.8%)	5	0/16 (0%)	0

Limitations/Caveats

Pilot study, Slow recruitment

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.