PDX-Transit: Dose-Responsive Effect of Polydextrose on Whole Gut Transit Time
Study Details
Study Description
Brief Summary
The aim of the study is to test the effect of polydextrose on whole gut transit time and gastrointestinal symptoms in a dose-responsive manner.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Given the promising, yet largely unsubstantiated, benefits of fiber supplementation, particularly polydextrose, on symptoms of functional constipation, the objective of this clinical trial is to evaluate the safety and effectiveness of 2-week supplementation of a proprietary polydextrose fiber product, in a dose-ranging fashion, on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Polydextrose, low dose Polydextrose, low dose |
Dietary Supplement: Polydextrose, low dose
4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
|
| Active Comparator: Polydextrose, medium dose Polydextrose, medium dose |
Dietary Supplement: Polydextrose, medium dose
8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
|
| Active Comparator: Polydextrose, high dose Polydextrose, high dose |
Dietary Supplement: Polydextrose, high dose
12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
|
| Placebo Comparator: Placebo powder Placebo powder |
Dietary Supplement: Placebo powder
Placebo powder will be mixed with beverage and consumed once per day for 2 weeks
|
Outcome Measures
Primary Outcome Measures
- Whole gut transit time [2 weeks]
Secondary Outcome Measures
- Patient assessment of constipation quality of life [2 weeks]
- Patient assessment of constipation symptoms [2 weeks]
- Bowel Function Index [2 weeks]
- Adequate relief of constipation [2 weeks]
- Bowel movement frequency [2 weeks]
- Stool consistency [2 weeks]
- Degree of straining [2 weeks]
- Subjective assessment of bowel emptying [2 weeks]
- Abdominal discomfort/bloating [2 weeks]
- Overall product satisfaction [2 weeks]
- Blood and urine safety analysis [2 weeks]
- Adverse events [2 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age between 18 and 70 years
-
Body mass index between 18.5 and 29.9 kg/m2 (encompasses normal weight and overweight)
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Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
Must meet 2 or more of the following criteria:
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Straining during at least 25% of defecations
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Lumpy or hard stools in at least 25% of defecations
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Sensation of incomplete evacuation for at least 25% of defecations
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Sensation of anorectal obstruction/blockage for at least 25% of defecations
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Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
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Fewer than three defecations per week
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Loose stools are rarely present without the use of laxatives
-
Insufficient criteria for irritable bowel syndrome
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Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects
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Consent to the study and willing to comply with study product and methods
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Willingness to maintain a stable diet throughout the study
-
Consistent use and dose of chronic medication, if any, in the past 30 days
Exclusion Criteria:
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Major gastrointestinal complication (e.g. Crohn"s disease, colitis, celiac disease)
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Febrile diverticulitis within 1 year of screening
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Pelvic floor dysfunction
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Prior abdominal surgery that in the opinion of the investigator may present a risk for the subject or confound study results
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Prior abdominal surgery of the following type: gastric bypass, lap band, colectomy, removal of gall bladder
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Clinically significant underlying systemic illness that may preclude the subject"s ability to complete the trial or that may confound the study outcomes
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Any clinically relevant abnormalities in the physical examination or in laboratory variables before entry into the study
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Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening
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Laxative, fiber supplement, or other constipation medication (e.g. prokinetic drugs) use within 2 weeks of screening
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Antibiotic use within 1 month of enrollment
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Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-HT#- antagonists, antacids with magnesium or aluminum, or diarrhea medication)
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Anticipated major dietary or exercise changes during the study period
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Known allergies to any substance in the study product
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Pregnant or lactating female, or pregnancy planned during study period
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Eating disorder
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History of alcohol, drug, or medication abuse
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Participation in another study with any investigational product within 3 months of screening
-
Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Istituto Clinico Humanitas | Milan | Italy | 20089 |
Sponsors and Collaborators
- Danisco
- Sprim Advanced Life Sciences
Investigators
- Principal Investigator: Silvio Danese, MD, Istituto Clinico Humanitas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Q-PRE-0111-CLI-007