- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07688044
The Role That Food and Bacteria Play in Generating Abdominal Pain
2026년 7월 13일 업데이트: David Reed
The Role of Gut Microbiota in Patient Responses to a Dietary Therapy for Abdominal Pain
Irritable Bowel Syndrom (IBS) affects up to five percent of Canadians and has proven difficult to treat.
Our research will explore how a type of dietary carbohydrate, called FODMAPS, contributes to chronic abdominal pain in irritable bowel syndrome (IBS).
FODMAPs, are poorly digested carbohydrates and removing FODMAPs from the diet relieves abdominal pain in approximately half of IBS patients.
Unfortunately, FODMAPs are contained in many foods, which makes it challenging for patients to remain on a low FODMAP diet for extended periods.
Our proposed research will identify which subtypes of FODMAPs are most responsible for increasing pain and will tease apart whether the pain-causing effects of FODMAPs rely on the gut microbiota or not.
To identify which specific type of FODMAP causes pain, IBS patients will adopt a low FODMAP diet and then individual FODMAP subtypes will be added back to their diet while monitoring changes to their pain.
Stool samples will be collected from the participants to determine whether the composition of the gut microbiota or the chemicals that it produces are changed when symptoms are improved or exacerbated by manipulating FODMAP availability.
In parallel studies, the microbiota of each IBS patient will be grown in specialized conditions to mimic the environment of the gut.
These patient microbial communities will be exposed to the same FODMAP manipulations as the patients themselves experience.
This will allow us to test whether the changes in gut microbiota composition and the chemicals produced that occur in IBS patients in response to FODMAP manipulations also occur when only the microbiota is exposed to these manipulations.
Together, these studies will aim to optimize a dietary therapy for a common chronic pain condition and will provide novel insights into how diet affects the chemicals the gut microbiota produces that contribute to abdominal pain.
연구 개요
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ontario
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Kingston, Ontario, 캐나다, K7L 5G2
- 모병
- Hotel Dieu Hospital
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연락하다:
- Celine Morissette
- 전화번호: (613) 449-5433
- 이메일: celine.morissette@kingstonhsc.ca
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adults aged 18-70 with IBS (Rome IV (now V) criteria)
- PROMIS belly pain score >12
Exclusion Criteria:
- Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.) as some symptoms may be related to their disease and not IBS.
- Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
- Major gastrointestinal surgery (e.g. Roux en y, bowel resection) as symptoms may be related to previous surgery rather than IBS.
- Body mass index above 35 kg/m2 as it is unknown how mediators in the GI tract that may be involved in pain signaling in the gut are affected by obesity.
- History of active cancer in the last 5 years, other than basal cell cancer as the treatment may have impacted the GI tract.
- Pregnant or breastfeeding women.
- Active or recent participation (< 1 month) in a clinical study.
- Use of antibiotics, probiotics, during, or one month prior to the study as may affect gut microbiota.
- Use of new medications less than 4 weeks prior to the study as may alter gut microbiota and/or IBS symptoms.
- Allergies to any of the ingredients used in the study.
- Any immune-compromising conditions as may affect GI symptoms.
- Currently being treated for eating disorder, schizophrenia, psychosis or other acute mental disorders as participating in a diet challenge study may have negative impact on these disorders.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: FODMAP Challenge
Participants will be on a low fodmap diet (LFD) for a total of 6 weeks.
After two weeks on LFD, each participant whose IBS-symptom severity score was reduced by 50 points will be deemed a responder, and will proceed to the next stage of the study.
This will entail each participant remaining on the LFD while beginning 4 four-day individual challenges every 7 days consisting of 3 FODMAP subgroup challenges (galacto-oligosaccahride, fructan, and sorbitol) and 1 glucose challenge as a non-FODMAP carbohydrate control.
Each challenge will comprise of a 4-day challenge with one of the three FODMAP subgroups or a glucose challenge (as a negative control) followed by a 3-day washout period with any residual symptoms resolved while remaining on the LFD prior to the next challenge.
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Prior to beginning the LFD, each participant will provide a stool sample.
This will be used to inoculate a continuous culture system (chemostat) as these vessels maintain fecal microbial communities under controlled anaerobic conditions.
After reaching steady state in culture media with FODMAPs (7 days), the media will be switched to a low FODMAP media for 7 days.
Then each vessel will be exposed to the same FODMAP subgroups challenges and glucose challenge as the participants for 3 days.
At each stage (i.e., steady state, after low fodmap media, after each challenge) culture supernatant will be collected.
This supernatant will be used to test its neurophysiological effects on pain sensing neurons in pre-clinical studies.
In addition, participants will provide a stool sample at each stage.
Fecal supernatants will be produced from these samples and the neurophysiological effects of the fecal supernatants will be tested in pre-clinical studies.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Dorsal Root Ganglion (DRG) neuron rheobase by chemostat supernatant
기간: 2-3 week of recording for each supernatant condition.
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DRG neurons will be incubated overnight with chemostat supernatant after steady state, low fodmap media, fodmap subtype media and glucose media.
Patch clamp recordings will be made from neurons the following day the rheobase (minimum current required to elicit an action potential in a neuron) will be measured.
The mean rheobase for neurons exposed to the different supernatant conditions will be compared.
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2-3 week of recording for each supernatant condition.
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Change in Dorsal Root Ganglion (DRG) neuron rheobase by fecal supernatant
기간: 2-3 weeks for each supernatant condition
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DRG neurons will be incubated overnight with fecal supernatant at baseline, after low fodmap diet, fodmap subtype challenge and glucose challenge.
Patch clamp recordings will be made from neurons the following day the rheobase (minimum current required to elicit an action potential in a neuron) will be measured.
The mean rheobase for neurons exposed to the different supernatant conditions will be compared.
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2-3 weeks for each supernatant condition
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Microbial community composition
기간: 6 weeks
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The chemostat cultures will be sampled after each stage (steady state, low fodmap media, fodmap subtype medias, glucose media) and analyzed
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6 weeks
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Irritable Bowel Syndrome (IBS) Symptom Severity Score
기간: 6 weeks
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IBS Symptom Severity Score (a score of 0 to 500, with higher scores indicating greater symptom severity) will be taken at baseline, after low fodmap diet, each fodmap subtype challenge and glucose challenge.
Change in IBS Symptom Severity Score as well as number of participants with a change of at least 50 points will be analyzed.
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6 weeks
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Patient-Reported Outcomes Measurement Information System Belly Pain Score
기간: 6 weeks
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These questionnaires will be administered at baseline, after low fodmap diet, each fodmap subtype challenge and glucose challenge.
The scores at each time point will be compared.
The raw scores are 2-25 and this is converted to a standardized T score.
Higher scores indicate a higher pain score.
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6 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 3월 16일
기본 완료 (추정된)
2030년 3월 1일
연구 완료 (추정된)
2031년 3월 1일
연구 등록 날짜
최초 제출
2026년 6월 30일
QC 기준을 충족하는 최초 제출
2026년 6월 30일
처음 게시됨 (실제)
2026년 7월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 13일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 6044324
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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