Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

NCT04667884 | Completed DMC

• 1 other identifier: 201911143
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

• Number of bowel movements per week

  bowel movements will be recorded per week

  week 0 to 4

Secondary Outcomes (8)

• Classification of bowel status

  day 0, 14, 28

• Bristol classification of stool characteristics

  day 0, 14, 28

• glucose

  day 0, 14, 28

• HDL-C

  day 0, 14, 28

• LDL-C

  day 0, 14, 28

Study Arms (5)

Group A

EXPERIMENTAL

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

Dietary Supplement: Prebiotics or Probiotics

Group B

EXPERIMENTAL

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

Dietary Supplement: Prebiotics or Probiotics

Group C

EXPERIMENTAL

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

Dietary Supplement: Prebiotics or Probiotics

Group D

EXPERIMENTAL

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

Dietary Supplement: Prebiotics or Probiotics

Group E

PLACEBO COMPARATOR

Maltodextrin， 3 g/d, 4 weeks

Dietary Supplement: Prebiotics or Probiotics

Interventions

Prebiotics or Probiotics DIETARY_SUPPLEMENT

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.

Group A; Group B; Group C; Group D; Group E

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

Study Sites (1)

Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (1)

• Lai H, Li Y, He Y, Chen F, Mi B, Li J, Xie J, Ma G, Yang J, Xu K, Liao X, Yin Y, Liang J, Kong L, Wang X, Li Z, Shen Y, Dang S, Zhang L, Wu Q, Zeng L, Shi L, Zhang X, Tian T, Liu X. Effects of dietary fibers or probiotics on functional constipation symptoms and roles of gut microbiota: a double-blinded randomized placebo trial. Gut Microbes. 2023 Jan-Dec;15(1):2197837. doi: 10.1080/19490976.2023.2197837.

  PMID: 37078654 DERIVED

MeSH Terms

Conditions

Constipation

Interventions

Prebiotics; Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Xin Liu

  Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: December 16, 2020
• Study Start: August 15, 2020
• Primary Completion: May 22, 2021
• Study Completion: September 30, 2021
• Last Updated: October 14, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)