An interventional study of Probiotic and Maltodextrin in Functional Constipation, sponsored by Wecare Probiotics Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Wecare Probiotics Co., Ltd. · Not applicable, Interventional, and Treatment
This study aims to evaluate the efficacy and safety of Bifidobacterium animalis subsp. lactis BLa36 in adults with functional constipation. In this randomized, double-blind, placebo-controlled trial, participants will receive BLa36 supplementation or placebo for 8 weeks. Clinical outcomes will be assessed using validated gastrointestinal symptom scales, stool characteristics, and quality-of-life measures. In addition, changes in inflammatory and immune markers, gut microbiota composition, metabolic indicators, and gut-brain axis-related parameters will be evaluated to comprehensively determine the effects of BLa36 on intestinal function and overall health.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's planned enrollment of 105 is above the median of 75 across 884 interventional studies indexed under Constipation.
Browse Constipation studies →Wecare Probiotics Co., Ltd. is the lead sponsor of 67 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will receive Bifidobacterium animalis subsp. lactis BLa36 at a dose of 3 g per sachet, administered once daily for 8 weeks.
Dietary Supplement: Probiotic
Participants in this group will receive a placebo containing maltodextrin (3 g per sachet), administered once daily for 8 weeks, matched in appearance and administration to the active product.
Dietary Supplement: Maltodextrin
Participants in this group will receive Bifidobacterium animalis subsp. lactis BLa36 at a dose of 3 g per sachet, administered once daily for 8 weeks.
Dietary Supplement: High-activity probiotic group
BLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.
Maltodextrin will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.
BLa36 will be administered orally once daily for 8 weeks. Follow-up assessments will be conducted at Week 0, Week 4, and Week 8.
Improvement of constipation symptoms
Improvement in constipation will be evaluated using the Bristol Stool Form Scale (BSFS), with particular focus on changes in stool form from type 1-2 (hard stools/constipation) toward type 3-4 (normal stool consistency).
Time frame: 8 weeks
Start is estimated for Jun 2026; primary completion for Nov 2026, 5 months later.
Of 71 industry-sponsored interventional studies with no phase under Constipation, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 5 months is below that.
Counting every sponsor, half of 314 studies reached it within 14 months; a quarter within 6 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic