Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

NCT ID: NCT04667884

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-15
• Study Completion Date: 2021-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

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

Group Type: EXPERIMENTAL

Prebiotics or Probiotics

Intervention Type: 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 B

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

Group Type: EXPERIMENTAL

Prebiotics or Probiotics

Intervention Type: 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 C

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

Group Type: EXPERIMENTAL

Prebiotics or Probiotics

Intervention Type: 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 D

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

Group Type: EXPERIMENTAL

Prebiotics or Probiotics

Intervention Type: 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 E

Maltodextrin， 3 g/d, 4 weeks

Group Type: PLACEBO_COMPARATOR

Prebiotics or Probiotics

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Jiaomei Yang

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Liu

Role: PRINCIPAL_INVESTIGATOR

Xi'an Jiaotong University

Locations

Xi'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 37078654 (View on PubMed)

Other Identifiers

201911143

Identifier Type: -

Identifier Source: org_study_id