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.
調査の概要
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ontario
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Kingston、Ontario、カナダ、K7L 5G2
- 募集
- Hotel Dieu Hospital
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コンタクト：
- Celine Morissette
- 電話番号：(613) 449-5433
- メール：celine.morissette@kingstonhsc.ca
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Dorsal Root Ganglion (DRG) neuron rheobase by chemostat supernatant
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Microbial community composition
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年3月16日
一次修了 (推定)
2030年3月1日
研究の完了 (推定)
2031年3月1日
試験登録日
最初に提出
2026年6月30日
QC基準を満たした最初の提出物
2026年6月30日
最初の投稿 (実際)
2026年7月7日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月15日
QC基準を満たした最後の更新が送信されました
2026年7月13日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。