CClinicalTrials.gg
CompletedNCT07649564Updated Jun 16, 2026

Probiotic for Alleviating Functional Constipation in Adults

An interventional study of Probiotic and Placebo in Con, Cons ti and Con s ti, sponsored by Wecare Probiotics Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jul 2024, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

To investigate the clinical effects of probiotics in relieving chronic constipation in adults, and evaluate the improvement of symptoms in patients with constipation as well as their impacts on gastrointestinal function and gut microbiota.

02

Conditions studied

  • Con
  • Cons ti
  • Con s ti
03

In context

Lead sponsor

Wecare Probiotics Co., Ltd. is the lead sponsor of 65 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

(1) Chinese adults aged 18-70 years who meet the Rome IV diagnostic criteria for chronic constipation (duration of at least 6 months, with less than three passing stools per week and/or Bristol Stool Scale types 1 and 2); (2) The patient rarely experiences diarrhea without using laxatives; (3) The criteria for irritable bowel syndrome were insufffcient ; (4) patients that could complete the study according to the requirements of the trial protocol; (5) participants (including male subjects) who have no family planning within 14 days prior to screening and voluntarily take effective contraceptive measures within 6 months after the end of the trial; (6) Patients capable of understanding the clinical study and willing to comply with the study requirements and procedures; (7) Subjects who have signed the informed consent form. Only those who meet all the above conditions can be selected for the study.

-

Exclusion criteria

Exclusion Criteria:

  1. Use of probiotics, prebiotics, or antibiotics within two weeks prior to enrollment and throughout the intervention period;
  2. Regular use of a high-fiber diet, as measured by the recommended food score (RFS);
  3. Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea;
  4. Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, ulcerative colitis, malignant tumor of the colon;
  5. Medical history of cardiovascular, liver, or renal diseases; alcoholics;
  6. Hypersensitivity to probiotics or the ingredients used in this study;
  7. Pregnancy or breastfeeding;
  8. Participation in another clinical trial in the 3 months before enrollment. -
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Probiotic Group

    Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8).

    Dietary Supplement: Probiotic

  • Placebo comparator
    Placebo Group

    Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8).

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementProbiotic

    During the intervention, participants can consume BC99 daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.

  • Dietary supplementPlacebo

    During the intervention, participants can consume maltodextrin daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.

06

What researchers measure

Primary outcomes

  1. 1. Assessing the Improvement of Chronic Constipation Symptoms Following Probiotic Intervention.

    Constipation symptoms are measured using Bristol Stool Form Scale, which classifies stool into seven types (1-2 indicate constipation, 3-4 normal, and 5-7 diarrhea) for self-assessment or clinical evaluation of bowel function.

    Time frame: 8 weeks

07

Study locations

1 site
  • The School of Food and Bioengineering, Henan University of Science and Technolog
    Luoyang, Henan 471000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07649564
Lead sponsor
Wecare Probiotics Co., Ltd.
Responsible party
Sponsor
First posted
Jun 16, 2026
Start date
Jul 2, 2024
Primary completion
Aug 9, 2024
Completion
Oct 4, 2024
Last update
Jun 16, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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