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Résztvevőt keres itt: KanadaFázis nélkül

The Role That Food and Bacteria Play in Generating Abdominal Pain

A legfontosabb adatok

Ki végzi
David Reed
Hol
Kingston (Kanada)A helyszín megnézése
Azonosító
Állapot
Toboroz
Résztvevők
60 fő, tervezett
Kezdés
2026. márc. 16.
Várható befejezés
2031. márc.
A vizsgálat típusa
Beavatkozással járó
A vizsgált kezelések
  • FODMAP Challenge
A regiszteradat frissítve
2026. július 15.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with irritable bowel syndrome (IBS) and belly pain. They will follow a low FODMAP diet, then foods are added back one type at a time.

Életkor
18 to 70 years
Nem
All sexes
A betegség stádiuma
IBS diagnosed by the Rome IV (now V) criteria, with a PROMIS belly pain score above 12.
Korábbi kezelés
No antibiotics or probiotics during the study or in the month before. No new medicines in the 4 weeks before the study. No major bowel surgery, such as Roux en y or bowel resection.

A részvétel fő kizáró okai

  • Other significant bowel disease, such as celiac disease or IBD
  • Body mass index above 35 kg/m2
  • Active cancer in the last 5 years, other than basal cell cancer
  • Pregnant or breastfeeding women
  • Immune system problems, or current treatment for an eating disorder, schizophrenia, psychosis or another acute mental disorder

A regiszter feltételei, szó szerint

Mind a 14 feltétel megnézéseKevesebb

Ki vehet részt

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

Ki nem vehet részt

  • Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.) as some symptoms may be related to their disease and not IBS
  • Major gastrointestinal surgery (e.g. Roux en y, bowel resection) as symptoms may be related to previous surgery rather than IBS
  • 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
  • History of active cancer in the last 5 years, other than basal cell cancer as the treatment may have impacted the GI tract
  • 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
  • Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection
  • 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
  • Pregnant or breastfeeding women
  • Active or recent participation (< 1 month) in a clinical study

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 70 év között vagy?

Helyszínek itt: Kanada

  • Hotel Dieu HospitalKingston, KanadaContact: Celine MorissetteRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A vizsgálat csoportja

  • FODMAP ChallengeA vizsgált kezelés

    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.

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
The Role of Gut Microbiota in Patient Responses to a Dietary Therapy for Abdominal Pain
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
Illeszkedési kérdések
Forrás: NCT07688044: ki vehet részt
A regiszteradat frissítve
2026. július 15.