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Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

Primary Purpose

Constipation

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Prebiotics or Probiotics

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Xi'an Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

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

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

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

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

Maltodextrin， 3 g/d, 4 weeks

Outcomes

Primary Outcome Measures

Number of bowel movements per week

bowel movements will be recorded per week

Secondary Outcome Measures

Classification of bowel status

Classification according to the difficulty of defecation 9/5000 According to the difficulty of defecation

Bristol classification of stool characteristics

Bristol classification

glucose

Fasting plasma

HDL-C

Fasting plasma

LDL-C

Fasting plasma

Tch

Fasting plasma

diversity and abundance of intestinal flora

16s rRNA

Full Information

NCT ID

NCT04667884

First Posted

August 7, 2020

Last Updated

October 12, 2021

Sponsor

Health Science Center of Xi'an Jiaotong University

1. Study Identification

Unique Protocol Identification Number

NCT04667884

Brief Title

Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

Official Title

Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation Among Adults

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

August 15, 2020 (Actual)

Primary Completion Date

May 22, 2021 (Actual)

Study Completion Date

September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Health Science Center of Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

250 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

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

Arm Title

Group B

Arm Type

Experimental

Arm Description

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

Arm Title

Group C

Arm Type

Experimental

Arm Description

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

Arm Title

Group D

Arm Type

Experimental

Arm Description

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

Arm Title

Group E

Arm Type

Placebo Comparator

Arm Description

Maltodextrin， 3 g/d, 4 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Prebiotics or Probiotics

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of bowel movements per week

Description

bowel movements will be recorded per week

Time Frame

week 0 to 4

Secondary Outcome Measure Information:

Title

Classification of bowel status

Description

Classification according to the difficulty of defecation 9/5000 According to the difficulty of defecation

Time Frame

day 0, 14, 28

Title

Bristol classification of stool characteristics

Description

Bristol classification

Time Frame

day 0, 14, 28

Title

glucose

Description

Fasting plasma

Time Frame

day 0, 14, 28

Title

HDL-C

Description

Fasting plasma

Time Frame

day 0, 14, 28

Title

LDL-C

Description

Fasting plasma

Time Frame

day 0, 14, 28

Title

Description

Fasting plasma

Time Frame

day 0, 14, 28

Title

Tch

Description

Fasting plasma

Time Frame

day 0, 14, 28

Title

diversity and abundance of intestinal flora

Description

16s rRNA

Time Frame

day 0, 14, 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xin Liu

Organizational Affiliation

Health Science Center of Xi'an Jiaotong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xi'an Jiaotong University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710061

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

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