Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

The Role That Food and Bacteria Play in Generating Abdominal Pain

13 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Dorsal Root Ganglion (DRG) neuron rheobase by chemostat supernatant
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Microbial community composition
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

David Reed

Medewerkers

Weston Family Foundation

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 maart 2026

Primaire voltooiing (Geschat)

1 maart 2030

Studie voltooiing (Geschat)

1 maart 2031

Studieregistratiedata

Eerst ingediend

30 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 juni 2026

Eerst geplaatst (Werkelijk)

7 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

13 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 6044324

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren