Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders (COLIPRAL)
3 de agosto de 2026 actualizado por: ZINGONE FABIANA, University of Padova
Evaluation of the Effects of Colipral® (E.Coli 5C LMG S-33222) on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders
The study is a double-blind, placebo-controlled, crossover, randomised trial, in which enrolled subjects will be included for 18 months. This study aims to evaluate the effect of the Colipral as a Food Supplement prescribed according to the standard of care of patients suffering UC during remission phase and DGBI.
The primary objective of the study is to evaluate the variation in gut microbiota, specifically focusing on bacterial diversity and abundance, in patients with UC during the remission phase and DGBI.
The secondary objective of the study is to evaluate the clinical parameters variations (based on fecal calprotectin and IBDQ's score before and after the treatment), the severity of gastrointestinal symptoms, the quality of life, and the maintenance of the remission phase in patients with UC in remission and DGBI.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
The primary endpoint will be the variation in gut microbiota analyzed through 16S rRNA gene sequencing from a fecal sample of patients presenting UC during remission phase and DGBI at three time points: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
The secondary endpoint will be the assessment of the clinical parameters variation based on fecal calprotectin in patients presenting UC during remission phase and DGBI at three time points: T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B).
The severity of gastrointestinal symptoms and quality of life will be assessed using the IBDQ, IBS SSS, VAS, and Bristol Stool Scale questionnaires at three time points: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B). Patients' dietary habits will be analysed using the WCRF questionnaire at the first and final visit.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
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
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Padova
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Padova, Padova, Italia, 35128
- Azienda Ospedale - Univeristà Padova
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Contacto:
- Fabiana Zingone
- Número de teléfono: +39 0498215656
- Correo electrónico: fabiana.zingone@unipd.it
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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:
- Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence.
- Disease in remission phase confirmed by clinical, endoscopic and histopathological evidence for at least 6 months
- Diagnosis of disorders of gut-brain interaction (DGBI): IBS-D, IBS-M, bloating, and abdominal pain
- Male/female
- Age in the range 18-70 years
- Subjects capable of conforming to the study protocol
- Subjects who have given their free and informed consent
Exclusion criteria:
- History of gastrointestinal disorders or gastrointestinal surgery interfering with gastrointestinal function
- Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
- Currently following a restrictive diet (for example low FODMAPs diet or vegan diet)
- Females of childbearing potential, in the absence of effective contraceptive methods
- Subjects who become unable to conform to protocol
- Recent history or suspicion of alcohol abuse or drug addiction
- Indication for the initiation of a new drug therapy during the study
- History of current or recent antibiotic or probiotics use within the last 30 days
- Subjects who are treated with antibiotics
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Dietary Supplement Group (Treatment A)
In this arm patients receive 2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days
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2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days
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Comparador de placebos: Placebo Group (Treatment B)
In this arm patients receive 2 tablets/day of placebo (1/breakfast, and 1/dinner, before the meal) for 60 days
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2 tablets/day of Placebo (1/breakfast, and 1/dinner, before the meal) for 60 days
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Microbiota gut composition
Periodo de tiempo: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
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The primary endpoint will be the variation in gut microbiota analyzed through 16S rRNA gene sequencing from a fecal sample of patients presenting UC during remission phase and DGBI.
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T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Fecal calprotectin levels
Periodo de tiempo: T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B)
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Concentration of fecal calprotectin measured in mg/Kg as an objective marker of intestinal inflammation.
Normal value is <250 mg/Kg, with higher values indicating active intestinal inflammation.
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T=0 (baseline, before treatment), T=1 (after an additional 60 days of treatment A or B), and T=3 (after 60 days of treatment A or B)
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Quality of life in patiets with inflammatory bowel disease
Periodo de tiempo: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
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Quality of life will be assessed using the IBDQ (Inflammatory Bowel Disease Questionnaire).
This is a 32-item questionnaire that evaluates symptoms and well-being over the prior two weeks using a 7-point scale from 1 (worst) to 7 (best).
Total scores range from 32 to 224, with higher scores indicating a better quality of life.
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T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
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Dietary habits
Periodo de tiempo: T=0 (baseline, before treatment) and T=3 (after taking both treatment A and treatment B)
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Patients' dietary habits will be analysed using the WCRF questionnaire, which assesses dietary habits, particularly the questions focus on common eating patterns.
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T=0 (baseline, before treatment) and T=3 (after taking both treatment A and treatment B)
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Gastrointestinal symptom severity in patients with Irritable Bowel Syndrome
Periodo de tiempo: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
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The severity of gastrointestinal symptoms will be assessed using IBS Symptom Severity Scale, which measures the intensity and frequency of abdominal pain, severity of abdominal distention, and dissatisfaction with bowel habits.
Scores on the IBS-SSS range from 0 to 500 with higher scores indicating more severe symptoms.
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T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
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Severity of gastrointestinal symptoms
Periodo de tiempo: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
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Severity of gastrointestinal symptoms will be assessed using the Visual Analog Scale (VAS) that measure for acute and chronic pain by making a handwritten mark on a 10-cm line (0 = "No Pain" to 100 = "Worst Imaginable Pain").
The patient marks a point on the line corresponding to their symptom intensity.
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T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
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Severity of gastrointestinal symptoms
Periodo de tiempo: T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
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Severity of gastrointestinal symptoms will be assessed using Bristol Stool Scale.
This is a chart that rate the stools into seven categories based on form and consistency.
Types 1,2 (constipation), types 3,4 (normal bowel function), types 5,6,7(diarrhea).
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T=0 (baseline, before treatment), T=1 (after 60 days of treatment A or B), and T=3 (after an additional 60 days of treatment A or B).
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
1 de marzo de 2028
Finalización del estudio (Estimado)
1 de marzo de 2028
Fechas de registro del estudio
Enviado por primera vez
29 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
3 de agosto de 2026
Publicado por primera vez (Actual)
7 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 6576/AO/26
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
De-identified individual participant data underlying the results reported in publications will be made available to qualified researchers upon reasonable request to the Principal Investigator, subject to approval of the study Sponsor and to a signed data access agreement.
Marco de tiempo para compartir IPD
Beginning 6 months after publication of the main results and ending 5 years thereafter.
Criterios de acceso compartido de IPD
Requests must include a methodologically sound proposal and will be evaluated by the Principal Investigator and the Sponsor; data will be shared after approval of the proposal and signature of a data access agreement.
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
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