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Clinical study on Bifidobacterium lactis BL-99 assisting to improve functional dyspepsia

Clinical study on Bifidobacterium lactis BL-99 assisting to improve functional dyspepsia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000041430
Enrollment
Unknown
Registered
2020-12-26
Start date
2020-12-26
Completion date
Unknown
Last updated
2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

functional dyspepsia

Interventions

Mild placebo:placebo
Mild low dose:Low dose of BL-99 powder
Mild high dose:high dose BL-99 power
Severe placebo:placebo
Severe low dose:drug and Low dose of BL-99 powder
severe high dose:drug and high dose of BL-99 powder

Sponsors

China Agricultural University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Aged 18-60 years; (2) the Roman IV diagnosis standard: one or more of the following symptoms, namely, postprandial fullness, early enough, epigastric pain, epigastric burning sensation, postprandial nausea or vomiting, belching and bloating gas, acid regurgitation, burning sensation, retrosternal pain or discomfort, such as the course more than 6 months, nearly three months of symptom onset; (3) Willing to provide demographic information (age, weight, height, etc.); (4) Be willing to and complete daily and weekly questionnaires on general health, intestinal function and gastrointestinal symptoms.

Exclusion criteria

Exclusion criteria: (1) Indigestion caused by serious organic lesions; (2) Pregnancy; (3) Smokers and alcoholics; (4) Take any medication for constipation or diarrhea; (5) Currently taking any anti-inflammatory medication regularly; (6) Usually eat fermented foods or probiotics (for example, yogurt containing live cultures or supplements); (7) Received antibiotics in the past three months; (8) A history of clinically significant diarrhea or C. diff infection in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Clinical symptom score;The metagenome of intestinal flora;IL-6;TNF-a;

Secondary

MeasureTime frame
Short Chain Fatty Acids;Pepsinogen I;Pepsinogen II;gastrin;Metabolites in feces;

Countries

China

Contacts

Public ContactWang Ran

College of Food Science and Nutritional Engineering, China Agricultural University

wangran8609@126.com+86 13811855282

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026