The Role That Food and Bacteria Play in Generating Abdominal Pain
The Role of Gut Microbiota in Patient Responses to a Dietary Therapy for Abdominal Pain
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Kingston, Ontario, Canadá, K7L 5G2
- Reclutamiento
- Hotel Dieu Hospital
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Contacto:
- Celine Morissette
- Número de teléfono: (613) 449-5433
- Correo electrónico: celine.morissette@kingstonhsc.ca
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 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.
- 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.
Plan de estudios
¿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)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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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.
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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.
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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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Dorsal Root Ganglion (DRG) neuron rheobase by chemostat supernatant
Periodo de tiempo: 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 Dorsal Root Ganglion (DRG) neuron rheobase by fecal supernatant
Periodo de tiempo: 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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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Microbial community composition
Periodo de tiempo: 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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Irritable Bowel Syndrome (IBS) Symptom Severity Score
Periodo de tiempo: 6 weeks
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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.
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6 weeks
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Patient-Reported Outcomes Measurement Information System Belly Pain Score
Periodo de tiempo: 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.
The raw scores are 2-25 and this is converted to a standardized T score.
Higher scores indicate a higher pain score.
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6 weeks
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Signos y Síntomas Digestivos
- Enfermedades intestinales
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Colon
- Enfermedades del Colon Funcionales
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Síndrome del intestino irritable
- Dolor abdominal
Otros números de identificación del estudio
Otros números de identificación del estudio
- 6044324
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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