Fecal Microbiota Transplantation in the Treatment of Major LARS

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University People's Hospital

About this trial

Randomized trial to assess FMT efficacy in improving bowel function for major LARS patients. 40 subjects, blinded, randomized to FMT or probiotics. Pre-post 16S sequencing, 4-week follow-up for bowel symptoms, 8-week microbiota analysis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

  • fecal microbiota transplantation

    Biological/Vaccine

    During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the experimental group receiving FMT solution matched to the patient's microbiota for intra-intestinal administration.

  • Formulated probiotic supplements

    Dietary supplement

    During the treatment, a colonoscopic colonic catheter will be placed via the anus, with the control group receiving a standardized probiotic formula.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Fecal flora transplantation groupExperimental treatment 1 intervention
Group B: Formulated probiotics groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

bowel function

LARS score

Time frame
4 weeks and 8 weeks
2

Shannon index

biodiversity monitoring

Time frame
8 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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