Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

Not Applicable

Completed

• Conditions: Constipation
• Interventions: Dietary Supplement: Prebiotics or Probiotics

• Registration Number: NCT04667884
• Lead Sponsor: Health Science Center of Xi'an Jiaotong University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-07
• Study Start: 2020-08-15
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-16
• Primary Completion: 2021-05-22
• Study Completion: 2021-09-30
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Prebiotics or Probiotics	a mixture of Fructooligosaccharide, water-soluble dietary fiber, polydextrose, and isomalt oligosaccharide, 12 g/d, 4 weeks
Group C	Prebiotics or Probiotics	a mixture of Polydextrose, wheat fiber, and Seed shell of Plantago rotundifolia, 12 g/d, 4 weeks
Group A	Prebiotics or Probiotics	a mixture of Xylooligosaccharides, Stachyose, Fructooligosaccharides, and Water-soluble Dietary Fiber, 12 g/d, 4 weeks
Group D	Prebiotics or Probiotics	a mixture of Fructooligosaccharides, Bifidobacterium lactis HN019 and Lactobacillus rhamnosus HN001, 3 g/d, 4 weeks
Group E	Prebiotics or Probiotics	Maltodextrin， 3 g/d, 4 weeks

Primary Outcome Measures

Name	Time	Method
Number of bowel movements per week	week 0 to 4	bowel movements will be recorded per week

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China