An Adaptive Basket Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Therapy in Management of Irritable Bowel Syndrome-diarrhea Predominant or Prevention of Recurrent Clostridioides Difficile Infection

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Record identity and dates

Source

ClinicalTrials.gov

Source record ID

NCT06948461

Title field or adapter rule

{'original_value': 'An Adaptive Basket Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Therapy in Management of Irritable Bowel Syndrome-diarrhea Predominant or Prevention of Recurrent Clostridioides Difficile Infection', 'source_field': 'protocolSection.identificationModule.officialTitle'}

Ingested At

2026-10-31T23:27:35.669713+00:00

Published At

2025-04-29T00:00:00+00:00

Record Updated At

2025-04-29

Source Retrieved At

2026-10-31T22:18:52.668840+00:00

Timestamp Basis

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Date limitation

ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions

["Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D)", "Recurrent Clostridioides Difficile Infection (rCDI)", "Fecal Microbiota Therapy (FMT)", "Irritable Bowel Syndrome (IBS)", "Clostridioides Difficile Infection"]

protocolSection.statusModule.lastUpdatePostDateStruct

{"date": "2025-04-29", "type": "ACTUAL"}

protocolSection.identificationModule.nctId

"NCT06948461"

protocolSection.identificationModule.officialTitle

"An Adaptive Basket Trial to Evaluate Efficacy of Lyophilized Fecal Microbiota Therapy in Management of Irritable Bowel Syndrome-diarrhea Predominant or Prevention of Recurrent Clostridioides Difficile Infection"

protocolSection.statusModule.overallStatus

"NOT_YET_RECRUITING"

protocolSection.designModule.phases

["PHASE2"]

protocolSection.statusModule.resultsFirstPostDateStruct

null

Study condition terms

• Irritable Bowel Syndrome, Diarrhea-Predominant (IBS-D) (protocolSection.conditionsModule.conditions)
• Recurrent Clostridioides Difficile Infection (rCDI) (protocolSection.conditionsModule.conditions)
• Fecal Microbiota Therapy (FMT) (protocolSection.conditionsModule.conditions)
• Irritable Bowel Syndrome (IBS) (protocolSection.conditionsModule.conditions)
• Clostridioides Difficile Infection (protocolSection.conditionsModule.conditions)

Interventions recorded in this study

• {'armGroupLabels': ['IBS-D - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks', 'IBS-D - ORAL-LYO-FMT 7 Weeks', 'Primary/1st rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks', 'Primary/1st rCDI - ORAL-LYO-FMT 7 Weeks', '≥2 rCDI - ORAL-LYO-FMT 4 Weeks + Placebo 3 Weeks', '≥2 rCDI - ORAL-LYO-FMT 7 Weeks'], 'description': 'An oral capsule formulation of lyophilized fecal microbiota. Participants receive 7 capsules, three times per week (Monday, Wednesday, Friday), for either 4 or 7 weeks depending on treatment allocation. The product aims to restore healthy gut microbiota for treatment of IBS-D or prevention of rCDI.', 'name': 'ORAL-LYO-FMT', 'type': 'BIOLOGICAL'} (protocolSection.armsInterventionsModule.interventions[])
• {'armGroupLabels': ['IBS-D - Placebo 7 Weeks', 'Primary/1st rCDI - Placebo 7 Weeks', '≥2 rCDI - Placebo 7 Weeks'], 'description': 'Double-coated oral capsules visually identical to ORAL-LYO-FMT but containing no active material. Participants receive 7 capsules, three times per week, for either 3 or 7 weeks depending on treatment allocation.', 'name': 'Placebo', 'type': 'OTHER'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

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