Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders (COLIPRAL)
3 août 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Padova
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Padova, Padova, Italie, 35128
- Azienda Ospedale - Univeristà Padova
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Contact:
- Fabiana Zingone
- Numéro de téléphone: +39 0498215656
- E-mail: fabiana.zingone@unipd.it
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Microbiota gut composition
Délai: 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 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.
|
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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Fecal calprotectin levels
Délai: 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
Délai: 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).
|
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
1 mars 2028
Achèvement de l'étude (Estimé)
1 mars 2028
Dates d'inscription aux études
Première soumission
29 juillet 2026
Première soumission répondant aux critères de contrôle qualité
3 août 2026
Première publication (Réel)
7 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 août 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 6576/AO/26
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime 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.
Délai de partage IPD
Beginning 6 months after publication of the main results and ending 5 years thereafter.
Critères d'accès au partage 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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