ConstipationNCT04667884

Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation

A study testing Prebiotics or Probiotics in people with Constipation, run by Xi'an Jiaotong University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Constipation
What is being tested?: Prebiotics or Probiotics
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 250 participants
Where: 1 siteChina
Study dates: 15 Aug 2020to 30 Sep 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

Conditions: Constipation
Being tested: Prebiotics or Probiotics
Medical subject headings: Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prebiotics or ProbioticsDietary 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.

Study groups in NCT04667884
Study group	Role	What they receive
Group A	Experimental	a mixture of Xylooligosaccharides, Stachyose, Fructooligosaccharides, and Water-soluble Dietary Fiber, 12 g/d, 4 weeks Receives: 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 Receives: 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 Receives: Dietary Supplement: Prebiotics or Probiotics
Group D	Experimental	a mixture of Fructooligosaccharides, Bifidobacterium lactis HN019 and Lactobacillus rhamnosus HN001, 3 g/d, 4 weeks Receives: Dietary Supplement: Prebiotics or Probiotics
Group E	Placebo comparator	Maltodextrin， 3 g/d, 4 weeks Receives: Dietary Supplement: Prebiotics or Probiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of bowel movements per week
bowel movements will be recorded per week
Measured: week 0 to 4

Secondary outcomes (8)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 202030 Sep 2021

First posted16 Dec 2020
Study start15 Aug 2020
Primary completion22 May 2021
Study completion30 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04667884
Sponsor's protocol ID: 201911143
Status last verified: Oct 2021
First submitted: 7 Aug 2020
Last updated: 14 Oct 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37078654

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

All Constipation trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Prebiotic or Probiotic Supplements on Symptoms of Functional Constipation Among Adults
ClinicalTrials.gov ID: NCT04667884
Acronym / sponsor ID: 201911143
Conditions: Constipation
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: Xi'an Jiaotong UniversityUniversity, hospital or other
Study start: 15 Aug 2020 (actual)
Primary completion: 22 May 2021 (actual)
Study completion: 30 Sep 2021 (actual)
First posted: 16 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Group A	Experimental	Dietary Supplement: Prebiotics or Probioticsa mixture of Xylooligosaccharides, Stachyose, Fructooligosaccharides, and Water-soluble Dietary Fiber, 12 g/d, 4 weeks
Group B	Experimental	Dietary Supplement: Prebiotics or Probioticsa mixture of Fructooligosaccharide, water-soluble dietary fiber, polydextrose, and isomalt oligosaccharide, 12 g/d, 4 weeks
Group C	Experimental	Dietary Supplement: Prebiotics or Probioticsa mixture of Polydextrose, wheat fiber, and Seed shell of Plantago rotundifolia, 12 g/d, 4 weeks
Group D	Experimental	Dietary Supplement: Prebiotics or Probioticsa mixture of Fructooligosaccharides, Bifidobacterium lactis HN019 and Lactobacillus rhamnosus HN001, 3 g/d, 4 weeks
Group E	Placebo comparator	Dietary Supplement: Prebiotics or ProbioticsMaltodextrin， 3 g/d, 4 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (10 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prebiotics or ProbioticsAll 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.	Dietary supplement	Group A, Group B, Group C, Group D, Group E

Primary outcome

Number of bowel movements per week
Time frame: week 0 to 4
bowel movements will be recorded per week

8 secondary outcomes

Classification of bowel status
Time frame: day 0, 14, 28
Bristol classification of stool characteristics
Time frame: day 0, 14, 28
glucose
Time frame: day 0, 14, 28
HDL-C
Time frame: day 0, 14, 28
LDL-C
Time frame: day 0, 14, 28
TG
Time frame: day 0, 14, 28
Tch
Time frame: day 0, 14, 28
diversity and abundance of intestinal flora
Time frame: day 0, 14, 28

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
Derived from this study: PubMed 37078654Lai 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.
Individual participant dataSharing planned: No

Related trials for Constipation

Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xin Liu principal investigator

Xi'an Jiaotong University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotics or Probiotics in people with Constipation, run by Xi'an Jiaotong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of bowel movements per week (time frame: week 0 to 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04667884, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.