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Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

Sponsor
Health Science Center of Xi'an Jiaotong University (Other)
Overall Status
Completed
CT.gov ID
NCT04667884
Collaborator
(none)
250
Enrollment
1
Location
5
Arms
13.5
Actual Duration (Months)
18.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study intends to evaluate the effects of three prebiotic solid beverages (mainly dietary fiber and prebiotics) and one probiotic solid beverage on the laxative effect of patients with functional constipation through randomized controlled trials. The influence of tract flora is expected to provide a basis for related therapies for patients with functional constipation.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Prebiotics or Probiotics
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation Among Adults
Actual Study Start Date :
Aug 15, 2020
Actual Primary Completion Date :
May 22, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

a mixture of Xylooligosaccharides, Stachyose, Fructooligosaccharides, and Water-soluble Dietary Fiber, 12 g/d, 4 weeks

Dietary Supplement: Prebiotics or Probiotics
All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.
Experimental: Group B

a mixture of Fructooligosaccharide, water-soluble dietary fiber, polydextrose, and isomalt oligosaccharide, 12 g/d, 4 weeks

Dietary Supplement: Prebiotics or Probiotics
All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.
Experimental: Group C

a mixture of Polydextrose, wheat fiber, and Seed shell of Plantago rotundifolia, 12 g/d, 4 weeks

Dietary Supplement: Prebiotics or Probiotics
All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.
Experimental: Group D

a mixture of Fructooligosaccharides, Bifidobacterium lactis HN019 and Lactobacillus rhamnosus HN001, 3 g/d, 4 weeks

Dietary Supplement: Prebiotics or Probiotics
All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.
Placebo Comparator: Group E

Maltodextrin， 3 g/d, 4 weeks

Dietary Supplement: Prebiotics or Probiotics
All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.

Outcome Measures

Primary Outcome Measures

  1. Number of bowel movements per week [week 0 to 4]

    bowel movements will be recorded per week

Secondary Outcome Measures

  1. Classification of bowel status [day 0, 14, 28]

    Classification according to the difficulty of defecation 9/5000 According to the difficulty of defecation

  2. Bristol classification of stool characteristics [day 0, 14, 28]

    Bristol classification

  3. glucose [day 0, 14, 28]

    Fasting plasma

  4. HDL-C [day 0, 14, 28]

    Fasting plasma

  5. LDL-C [day 0, 14, 28]

    Fasting plasma

  6. TG [day 0, 14, 28]

    Fasting plasma

  7. Tch [day 0, 14, 28]

    Fasting plasma

  8. diversity and abundance of intestinal flora [day 0, 14, 28]

    16s rRNA

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Adults: 18 to 70 years old (not less than 50% of the final population over 45 years old, and not less than 30% of men);

  2. Patients with functional constipation (refer to Rome IV diagnostic criteria for functional constipation); * Symptoms appeared for at least 6 months before diagnosis, and met the above diagnostic criteria in the past 3 months

Exclusion Criteria:

  1. Pregnant and lactating women;

  2. Unable to take the test sample and complete the inspection items as required due to inability to take food by mouth, weakness, allergies or other reasons (including the inability to complete all items due to recent travel plans);

  3. Unclear main complaint and obvious abnormal mental state;

  4. The liver and kidney function indexes are obviously abnormal (combined with the results of physical examination within the past 1 year);

  5. Acute gastrointestinal diseases occurred in the past month, and constipation caused by surgical operations in the past month;

  6. Take antibiotics, laxatives or topical agents, anticholinergics, antidiarrheals frequently in the past 1 month, and the frequency is more than 1 time/week

  7. Have been diagnosed with the following diseases: cancer (especially cancer of the digestive tract), severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness;

  8. Have been diagnosed with the following diseases: severe systemic diseases such as stroke, heart disease, liver cirrhosis, renal failure, hematopoietic system, or qualitative intestinal diseases caused by colonoscopy or imaging display;

  9. In the past 3 months, there are often abdominal pain, abdominal pain accompanied by changes in bowel characteristics or frequency, blood in the stool, diarrhea or involuntary weight loss;

  10. Clinical manifestations or diseases that other researchers believe are not suitable for participating in the project.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xi'an Jiaotong University Xi'an Shaanxi China 710061

Sponsors and Collaborators

  • Health Science Center of Xi'an Jiaotong University

Investigators

  • Principal Investigator: Xin Liu, Health Science Center of Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiaomei Yang, Assistant Professor, Health Science Center of Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT04667884
Other Study ID Numbers:
  • 201911143
First Posted:
Dec 16, 2020
Last Update Posted:
Oct 14, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Constipation

Study Results

No Results Posted as of Oct 14, 2021