- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07688044
The Role That Food and Bacteria Play in Generating Abdominal Pain
30. juni 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ontario
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Kingston, Ontario, Canada, K7L 5G2
- Rekruttering
- Hotel Dieu Hospital
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Kontakt:
- Celine Morissette
- Telefonnummer: (613) 449-5433
- E-mail: celine.morissette@kingstonhsc.ca
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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 30 kg/m2 as it is known 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: FODMAP Challenge
Participants will be on a low fodmap diet (LFD) for a total of 6 weeks b.
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, which 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-oligosaccahrides, 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 listed below 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 followed by 3 day challenge.
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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in DRG neuron rheobase by chemostat supernatant
Tidsramme: 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 DRG neuron rheobase by fecal supernatant
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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IBS Symptom Severity Score
Tidsramme: 6 weeks
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IBS-SSS will be taken at baseline, after low fodmap diet, each fodmap subtype challenge and glucose challenge.
Change in IBS-SSS 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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PROMIS Belly Pain Score
Tidsramme: 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.
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6 weeks
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Microbial community composition
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. marts 2026
Primær færdiggørelse (Anslået)
1. marts 2030
Studieafslutning (Anslået)
1. marts 2031
Datoer for studieregistrering
Først indsendt
30. juni 2026
Først indsendt, der opfyldte QC-kriterier
30. juni 2026
Først opslået (Faktiske)
7. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6044324
Plan for individuelle deltagerdata (IPD)
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Kliniske forsøg med Irritabel tyktarm (IBS)
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Guy BoeckxstaensFund for Scientific Research, Flanders, BelgiumRekruttering
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Kyle Staller, MD, MPHArdelyxAfsluttetIBS - Irritabel tyktarm | IBSForenede Stater
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Mark Pimentel, MDRekrutteringIBS (irritabel tyktarm) | IBS-D (Diarré-dominerende)Forenede Stater
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Devintec SaglRekrutteringIrritabel tyktarm (IBS) | Irritabel tyktarm af diarré type (IBS-D)Italien, Spanien, Frankrig, Belgien
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Dr Anthony HobsonAfsluttetIrritabel tyktarm (IBS) | Irritabel tyktarm med diarré (IBS-D)Det Forenede Kongerige
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Seoul National University HospitalUkendtSund og rask | Kronisk forstoppelse | Constipated Irritable Bowel Syndrome
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University of California, Los AngelesRekruttering
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Sahlgrenska University HospitalAfsluttetIBS - Irritabel tyktarmSverige
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dsm-firmenich Switzerland AGRekruttering
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NYU Langone HealthIkke rekrutterer endnuIBS - Irritabel tyktarmForenede Stater
Kliniske forsøg med FODMAP Challenge
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Vendsyssel HospitalAfsluttet
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Oh Yoen KimDong-A UniversityAfsluttet
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Ashok TutejaUnited States Department of DefenseUkendt
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University Hospital Schleswig-HolsteinTrukket tilbage
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University of MichiganAfsluttet
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Beth Israel Deaconess Medical CenterUniversity of MichiganAfsluttet
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Tel-Aviv Sourasky Medical CenterUkendtEffektiviteten af FODMAP-diæt i Israel til at lindre symptomer hos patienter med irritabel tyktarmIrritabelt tarmsyndromIsrael
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Medical University of WarsawNutricia FoundationAfsluttet
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Weizmann Institute of ScienceRekrutteringIrritabelt tarmsyndromIsrael
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Beth Israel Deaconess Medical CenterAfsluttet