The Role That Food and Bacteria Play in Generating Abdominal Pain
2026年7月13日 更新者: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.
研究概览
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Ontario
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Kingston、Ontario、加拿大、K7L 5G2
- 招聘中
- Hotel Dieu Hospital
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接触:
- Celine Morissette
- 电话号码:(613) 449-5433
- 邮箱:celine.morissette@kingstonhsc.ca
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Dorsal Root Ganglion (DRG) neuron rheobase by chemostat supernatant
大体时间: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
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Microbial community composition
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年3月16日
初级完成 (估计的)
2030年3月1日
研究完成 (估计的)
2031年3月1日
研究注册日期
首次提交
2026年6月30日
首先提交符合 QC 标准的
2026年6月30日
首次发布 (实际的)
2026年7月7日
研究记录更新
最后更新发布 (实际的)
2026年7月15日
上次提交的符合 QC 标准的更新
2026年7月13日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.