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The Role That Food and Bacteria Play in Generating Abdominal Pain

13 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Ontario
      • Kingston, Ontario, Canadá, K7L 5G2

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Dorsal Root Ganglion (DRG) neuron rheobase by chemostat supernatant
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Microbial community composition
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de marzo de 2026

Finalización primaria (Estimado)

1 de marzo de 2030

Finalización del estudio (Estimado)

1 de marzo de 2031

Fechas de registro del estudio

Enviado por primera vez

30 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de junio de 2026

Publicado por primera vez (Actual)

7 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

13 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 6044324

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .