--- title: Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome nct_id: NCT00135031 overall_status: COMPLETED phase: PHASE3 sponsor: Procter and Gamble study_type: INTERVENTIONAL primary_condition: Irritable Bowel Syndrome countries: United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00135031.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00135031" ct_last_update_post_date: 2011-06-15 last_seen_at: "2026-05-12T07:10:31.885Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome **Official Title:** A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Safety and Efficacy Evaluation of Bifidobacterium Infantis 35624 in Female Subjects With Irritable Bowel Syndrome **NCT ID:** [NCT00135031](https://clinicaltrials.gov/study/NCT00135031) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 362 - **Lead Sponsor:** Procter and Gamble - **Collaborators:** Alimentary Health Ltd - **Conditions:** Irritable Bowel Syndrome - **Start Date:** 2004-01 - **Completion Date:** 2004-09 - **CT.gov Last Update:** 2011-06-15 ## Brief Summary The purpose of this study was to determine the dose-ranging efficacy and safety profile of encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome (IBS). ## Detailed Description The pathogenesis of irritable bowel syndrome (IBS) may have a a post-infectious inflammatory component, suggesting that altered gut bacterial flora are of relevance and that probiotics may be beneficial. This clinical trial examined the efficacy of an encapsulated probiotic in subjects with Rome II IBS. After a 2 week baseline, 362 female subjects were randomized to placebo or one of three doses of B. infantis 35624 once daily for 4 weeks. IBS symptoms were monitored daily and scored according to a 6-point Likert scale; stool frequency and form were also monitored daily. The primary efficacy variable was the abdominal pain score; secondary efficacy variables included other IBS symptom relief and quality of life. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 65 Years - **Sex:** FEMALE - **Healthy Volunteers:** No ``` Inclusion Criteria: * Meet Rome II criteria for the diagnosis of IBS * Refrain from using probiotic supplements during the trial Exclusion Criteria: * Organic diseases, including inflammatory bowel disease, and significant systemic diseases * Subjects over 55 years of age that had not had a sigmoidoscopy or colonoscopy performed in the previous five years * Use of anti-psychotic medications within the prior three months * Had major psychiatric disorder (DSM-II-R or DSM-IV), including major depression, psychoses, alcohol or substance abuse, within the past two years * Were pregnant or nursing * Had known lactose intolerance or immunodeficiency * Had undergone any abdominal surgery, with the exception of hernia repair or appendectomy ``` ## Interventions - **Bifidobacterium infantis 35624** (DRUG) ## Primary Outcomes - **The primary efficacy variable was the abdominal pain score** ## Secondary Outcomes - **Bloating/distension, sense of incomplete evacuation, straining, urgency, passage of gas, number of bowel movements, passage of mucus, a composite symptom score, subject's assessment of IBS symptom relief, and quality of life** ## Locations (20) - The Orchard Medical Centre, Bristol, Bristol, United Kingdom - Yaxley Group Practice, The Health Centre, Peterborough, Cambridgeshire, United Kingdom - The Staploe Medical Centre, Soham, Cambridgeshire, United Kingdom - Wansford Surgery, Wansford, Cambridgeshire, United Kingdom - Old School Surgery, Greenisland, County Antrim, United Kingdom - Springhill Surgery, Bangor, County Down, United Kingdom - Downpatrick Health Centre, Downpatrick, County Down, United Kingdom - Little Common Surgery, Bexhill-on-Sea, East Sussex, United Kingdom - Sea Road Surgery, Bexhill-on-Sea, East Sussex, United Kingdom - Valleyfield Health Centre, High Valleyfield, Fife, United Kingdom - Stanwell Road Surgery, Ashford, Middlesex, United Kingdom - Belmont Health Centre, Harrow, Middlesex, United Kingdom - The Frome Medical Practice, Frome, Somerset, United Kingdom - The Burns Practice, Doncaster, South Yorkshire, United Kingdom - The Burngreave Surgery, Sheffield, South Yorkshire, United Kingdom - The Medical Centre, East Horsley, Surrey, United Kingdom - The Penylan Surgery, Cardiff, Wales, United Kingdom - Sherbourne Medical Centre, Royal Leamington Spa, Warwickshire, United Kingdom - Hathaway Surgery, Chippenham, Wiltshire, United Kingdom - Swindon Medical Research Centre, Abbeymeads Medical, Swindon, Wiltshire, United Kingdom ## Recent Field Changes (last 30 days) - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.the orchard medical centre|bristol|bristol|united kingdom` — added _(2026-05-12)_ - `locations.yaxley group practice, the health centre|peterborough|cambridgeshire|united kingdom` — added _(2026-05-12)_ - `locations.the staploe medical centre|soham|cambridgeshire|united kingdom` — added _(2026-05-12)_ - `locations.wansford surgery|wansford|cambridgeshire|united kingdom` — added _(2026-05-12)_ - `locations.old school surgery|greenisland|county antrim|united kingdom` — added _(2026-05-12)_ - `locations.springhill surgery|bangor|county down|united kingdom` — added _(2026-05-12)_ - `locations.downpatrick health centre|downpatrick|county down|united kingdom` — added _(2026-05-12)_ - `locations.little common surgery|bexhill-on-sea|east sussex|united kingdom` — added _(2026-05-12)_ - `locations.sea road surgery|bexhill-on-sea|east sussex|united kingdom` — added _(2026-05-12)_ - `locations.valleyfield health centre|high valleyfield|fife|united kingdom` — added _(2026-05-12)_ - `locations.stanwell road surgery|ashford|middlesex|united kingdom` — added _(2026-05-12)_ - `locations.belmont health centre|harrow|middlesex|united kingdom` — added _(2026-05-12)_ - `locations.the frome medical practice|frome|somerset|united kingdom` — added _(2026-05-12)_ - `locations.the burns practice|doncaster|south yorkshire|united kingdom` — added _(2026-05-12)_ - `locations.the burngreave surgery|sheffield|south yorkshire|united kingdom` — added _(2026-05-12)_ - `locations.the medical centre|east horsley|surrey|united kingdom` — added _(2026-05-12)_ - `locations.the penylan surgery|cardiff|wales|united kingdom` — added _(2026-05-12)_ - `locations.sherbourne medical centre|royal leamington spa|warwickshire|united kingdom` — added _(2026-05-12)_ - `locations.hathaway surgery|chippenham|wiltshire|united kingdom` — added _(2026-05-12)_ - `locations.swindon medical research centre, abbeymeads medical|swindon|wiltshire|united kingdom` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00135031.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00135031* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*