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The Role That Food and Bacteria Play in Generating Abdominal Pain

13 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 5G2

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Adults aged 18-70 with IBS (Rome IV (now V) criteria)
  • PROMIS belly pain score >12

Exclusion Criteria:

  1. Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.) as some symptoms may be related to their disease and not IBS.
  2. Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
  3. Major gastrointestinal surgery (e.g. Roux en y, bowel resection) as symptoms may be related to previous surgery rather than IBS.
  4. 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.
  5. History of active cancer in the last 5 years, other than basal cell cancer as the treatment may have impacted the GI tract.
  6. Pregnant or breastfeeding women.
  7. Active or recent participation (< 1 month) in a clinical study.
  8. Use of antibiotics, probiotics, during, or one month prior to the study as may affect gut microbiota.
  9. Use of new medications less than 4 weeks prior to the study as may alter gut microbiota and/or IBS symptoms.
  10. Allergies to any of the ingredients used in the study.
  11. Any immune-compromising conditions as may affect GI symptoms.
  12. 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: FODMAP Challenge
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in Dorsal Root Ganglion (DRG) neuron rheobase by chemostat supernatant
Délai: 2-3 week of recording for each supernatant condition.
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.
2-3 week of recording for each supernatant condition.
Change in Dorsal Root Ganglion (DRG) neuron rheobase by fecal supernatant
Délai: 2-3 weeks for each supernatant condition
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.
2-3 weeks for each supernatant condition

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Microbial community composition
Délai: 6 weeks
The chemostat cultures will be sampled after each stage (steady state, low fodmap media, fodmap subtype medias, glucose media) and analyzed
6 weeks
Irritable Bowel Syndrome (IBS) Symptom Severity Score
Délai: 6 weeks
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.
6 weeks
Patient-Reported Outcomes Measurement Information System Belly Pain Score
Délai: 6 weeks
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.
6 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

David Reed

Collaborateurs

Weston Family Foundation

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

16 mars 2026

Achèvement primaire (Estimé)

1 mars 2030

Achèvement de l'étude (Estimé)

1 mars 2031

Dates d'inscription aux études

Première soumission

30 juin 2026

Première soumission répondant aux critères de contrôle qualité

30 juin 2026

Première publication (Réel)

7 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

15 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 6044324

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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