B.Subtilis Attenuate Symptoms in Diarrhea-predominant Irritable Bowel Syndrome by Increasing Hypoxanthine Biosynthesis

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age16-80
SponsorJinling Hospital, China

About this trial

This is a prospective, single-blind, randomized parallel study to investigate whether B. subtilis could improve clinical symptoms of IBS-D patients. Patients are randomly assigned by envelope method. A senior gastroenterologist is responsible for prescribing medication. Researchers are blind to patients' medication. Participants with IBS are recruited and randomized to receive a 4-week administration of B. subtilis-based probiotics. Clinical symptoms and stool samples are collected before and after the trial.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • B. subtilis

    Drug

    2 capsules, 3 times a day, orally taken for one month

  • Dead B. subtilis

    Drug

    2 capsules, 3 times a day, orally taken for one month

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: B. subtilis interventionActive comparator 1 intervention
Group B: Placebo capsulesPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The score of IBS-SSS before and after intervention

Time frame
6 months

Secondary outcomes

1

The concentration of purine in the stool before and after intervention

Time frame
6 months

Other outcomes

Sponsors and contacts

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