Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

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: Constipation
• Intervention / Treatment: Dietary supplement: Prebiotics or Probiotics

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Xi'an Jiaotong University

Participation Criteria

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of bowel movements per week	bowel movements will be recorded per week	week 0 to 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Classification of bowel status	Classification according to the difficulty of defecation 9/5000 According to the difficulty of defecation	day 0, 14, 28
Bristol classification of stool characteristics	Bristol classification	day 0, 14, 28
glucose	Fasting plasma	day 0, 14, 28
HDL-C	Fasting plasma	day 0, 14, 28
LDL-C	Fasting plasma	day 0, 14, 28
TG	Fasting plasma	day 0, 14, 28
Tch	Fasting plasma	day 0, 14, 28
diversity and abundance of intestinal flora	16s rRNA	day 0, 14, 28

Collaborators and Investigators

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

Study record dates

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: Signs and Symptoms, Digestive; Constipation
• 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