- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04667884
Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation
October 12, 2021 updated by: Jiaomei Yang, Health Science Center of Xi'an Jiaotong University
Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation Among Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
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Xi'an, Shaanxi, China, 710061
- Xi'an Jiaotong University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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);
- 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:
- Pregnant and lactating women;
- 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);
- Unclear main complaint and obvious abnormal mental state;
- The liver and kidney function indexes are obviously abnormal (combined with the results of physical examination within the past 1 year);
- Acute gastrointestinal diseases occurred in the past month, and constipation caused by surgical operations in the past month;
- Take antibiotics, laxatives or topical agents, anticholinergics, antidiarrheals frequently in the past 1 month, and the frequency is more than 1 time/week
- Have been diagnosed with the following diseases: cancer (especially cancer of the digestive tract), severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness;
- 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;
- 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;
- Clinical manifestations or diseases that other researchers believe are not suitable for participating in the project.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
a mixture of Xylooligosaccharides, Stachyose, Fructooligosaccharides, and Water-soluble Dietary Fiber, 12 g/d, 4 weeks
|
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
|
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
|
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
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of bowel movements per week
Time Frame: week 0 to 4
|
bowel movements will be recorded per week
|
week 0 to 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Classification of bowel status
Time Frame: day 0, 14, 28
|
Classification according to the difficulty of defecation 9/5000 According to the difficulty of defecation
|
day 0, 14, 28
|
Bristol classification of stool characteristics
Time Frame: day 0, 14, 28
|
Bristol classification
|
day 0, 14, 28
|
glucose
Time Frame: day 0, 14, 28
|
Fasting plasma
|
day 0, 14, 28
|
HDL-C
Time Frame: day 0, 14, 28
|
Fasting plasma
|
day 0, 14, 28
|
LDL-C
Time Frame: day 0, 14, 28
|
Fasting plasma
|
day 0, 14, 28
|
TG
Time Frame: day 0, 14, 28
|
Fasting plasma
|
day 0, 14, 28
|
Tch
Time Frame: day 0, 14, 28
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Fasting plasma
|
day 0, 14, 28
|
diversity and abundance of intestinal flora
Time Frame: day 0, 14, 28
|
16s rRNA
|
day 0, 14, 28
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xin Liu, Health Science Center of Xi'an Jiaotong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2020
Primary Completion (Actual)
May 22, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
August 7, 2020
First Submitted That Met QC Criteria
December 14, 2020
First Posted (Actual)
December 16, 2020
Study Record Updates
Last Update Posted (Actual)
October 14, 2021
Last Update Submitted That Met QC Criteria
October 12, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201911143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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