Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy (CLEAN+)
6 juillet 2026 mis à jour par: Fundacion Clinic per a la Recerca Biomédica
Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy: a Randomized Parallel Comparative Trial CLEAN+
Study to evaluate the efficacy and tolerability of a simethicone-containing evacuating solution for colorectal cancer screening colonoscopy.
Aperçu de l'étude
Statut
Recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
818
Phase
- Phase 4
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.
Coordonnées de l'étude
- Nom: Maria Pellisé
- Numéro de téléphone: +34 932275400
- E-mail: MPELLISE@clinic.cat
Sauvegarde des contacts de l'étude
- Nom: Judit Pich
- Numéro de téléphone: 2815 +34 932275400
- E-mail: JPICH@recerca.clinic.cat
Lieux d'étude
-
-
Barcelona
-
Barcelona, Barcelona, Espagne, 08036
- Recrutement
- Hospital Clinic de Barcelona
-
Chercheur principal:
- Maria Pellisé
-
Contact:
- Maria Pellisé
- E-mail: MPELLISE@clinic.cat
-
-
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:
- Men and women aged 50 to 69.
- Have participated in the early detection program for colorectal cancer.
- Positive result in the fecal occult blood test (≥20 μg Hb/g feces).
- Scheduled screening colonoscopy at Hospital Clínic de Barcelona.
- Signed informed consent form.
Exclusion Criteria:
- Severe renal failure (grade IV or V) (Annex 6, Stages of Renal Impairment) and/or congestive heart failure (New York Heart Association Scale Class III and IV) (Annex 7, NYHA Scale).
- Colonoscopy within the last year.
- Barthel Index of <20 (Annex 5, Barthel Index) and who also meet the Rome IV Criteria for the diagnosis of functional constipation (Annex 8, Rome IV Criteria).
- Mental disability or severe mental disorder (schizophrenia and other psychotic disorders, recurrent severe major depressive disorders, severe obsessive-compulsive disorder, severe personality disorders, and bipolar disorders).
- Do not understand spoken or written Catalan or Spanish.
- Partial or total colon resection.
- Personal history of CRC or colorectal pathology that requires specific follow-up (ulcerative colitis, Crohn's disease, or colorectal adenomas).
- Terminal illness or serious illness/disability that contraindicates subsequent colon study.
- Gastrointestinal disorders that contraindicate the use of study products (gastric emptying disorders, gastrointestinal perforation or obstruction, ileus, toxic megacolon).
- Hypermagnesemia.
- Rhabdomyolysis.
- Phenylketonuria.
- Glucose-6-phosphate dehydrogenase deficiency.
- Hypersensitivity to the active ingredients of excipients.
- Pregnancy or breastfeeding.
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: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Clensia®
Clensia®, powder for oral solution in sachet.
To be taken in two doses, 4 sachets dissolved in 200cc of water 9-12 hours before the examination and 4 sachets dissolved in 200cc of water 4 hours before the examination.
|
Participants will take the treatment in two doses, 4 sachets dissolved in 200cc of water 9-12 hours before the examination and 4 sachets dissolved in 200cc of water 4 hours before the examination.
|
|
Expérimental: Citrafleet®
Citrafleet®, powder for oral solution in sachet.
To be taken in two doses, 1 sachet dissolved in 200cc of water 9-12 hours before the examination and 1 sachet dissolved in 200cc of water 4 hours before the examination.
|
Participants will take the treatment in two doses, 1 sachet dissolved in 200cc of water 9-12 hours before the examination and 1 sachet dissolved in 200cc of water 4 hours before the examination.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adenoma detection rate
Délai: week 2 (Colonoscopy visit)
|
Adenoma detection rate, defined as the proportion of patients with at least one adenoma in relation to the total number of subjects in each study group (Clensia® Group (Group A); Citrafleet® Group (Group B)).
|
week 2 (Colonoscopy visit)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Lesion detection rate
Délai: week 2 (Colonoscopy visit)
|
Lesion detection rate, defined as the proportion of patients with at least one polyp in relation to the total number of subjects in each group.
|
week 2 (Colonoscopy visit)
|
|
Adenomas per colonoscopy
Délai: week 2 (Colonoscopy visit)
|
Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.
|
week 2 (Colonoscopy visit)
|
|
Presence of foam
Délai: week 2 (Colonoscopy visit)
|
The presence of foam using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying >50% of the circumference, obscuring the mucosa and require ring additional time to washing).
|
week 2 (Colonoscopy visit)
|
|
Presence of bubbles
Délai: week 2 (Colonoscopy visit)
|
The presence of bubbles using the CEBuS (Colon Endoscopic Bubble Scale), in which each colonic segment (right colon, transverse colon, left colon) is scored from 0 to 2 (0=no or minimal number of bubbles; 1=moderate amount of bubbles affecting 5-50% of the circumference, affecting the vision of the mucosa and requiring additional time to wash; 2=abundant bubbles occupying >50% of the circumference, obscuring the mucosa and require ring additional time to washing).
|
week 2 (Colonoscopy visit)
|
|
Quality of colon cleansing
Délai: week 2 (Colonoscopy visit)
|
The quality of colon cleansing using the Boston Scale, in which each colonic segment (right colon, transverse colon, and left colon) is scored from 0 to 3 (0=poor, 1=fair, 2=good, 3=excellent).
A total score greater than or equal to 6 and greater than or equal to 2 in each segment will be considered adequate.
|
week 2 (Colonoscopy visit)
|
|
Need for washing tools during colonoscopy
Délai: week 2 (Colonoscopy visit)
|
Need for washing tools during colonoscopy.
The amount of wash water used during the colonoscopy to complete the test satisfactorily is counted.
Likewise, the volume of simethicone used will be counted if it is considered necessary.
|
week 2 (Colonoscopy visit)
|
|
Cecal intubation rate
Délai: week 2 (Colonoscopy visit)
|
Cecal intubation rate.
The colonoscopy will be considered complete if the cecum has been reached; otherwise, it will be considered incomplete.
|
week 2 (Colonoscopy visit)
|
|
Cecal intubation time
Délai: week 2 (Colonoscopy visit)
|
Cecal intubation time.
Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus.
|
week 2 (Colonoscopy visit)
|
|
Endoscope removal time
Délai: week 2 (Colonoscopy visit)
|
Endoscope removal time.
Defined as the time elapsed between reaching the cecal fundus and completion of the endoscopy, including the time spent cleaning the colon and excluding endoscopic treatment of lesions.
|
week 2 (Colonoscopy visit)
|
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Requires repeat colonoscopy due to poor preparation
Délai: week 2 (Colonoscopy visit)
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Proportion of patients who, after undergoing colonoscopy, require repeat colonoscopy due to poor preparation, defined as a total score of less than 6 or less than 2 in one of the three segments according to the Boston Scale
|
week 2 (Colonoscopy visit)
|
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Adherence to the intake of the preparation
Délai: week 2 (Colonoscopy visit)
|
Adherence to the intake of the preparation assessed by compliance with the intake in three degrees: completely, more than 50%, less than 50% or not at all (Tolerability and satisfaction questionnaire).
|
week 2 (Colonoscopy visit)
|
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Ease of taking the preparation
Délai: week 2 (Colonoscopy visit)
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Ease of taking the preparation assessed with a numerical assessment scale from 0=very difficult to 10=very easy (Tolerability and satisfaction questionnaire).
|
week 2 (Colonoscopy visit)
|
|
Palatability of the preparation
Délai: week 2 (Colonoscopy visit)
|
Palatability of the preparation assessed with a numerical assessment scale from 0=very bad to 10=excellent (Tolerability and satisfaction questionnaire).
|
week 2 (Colonoscopy visit)
|
|
Willingness to repeat the intake of the preparation
Délai: week 2 (Colonoscopy visit)
|
Willingness to repeat the intake of the preparation assessed as yes or no (Tolerability and satisfaction questionnaire).
|
week 2 (Colonoscopy visit)
|
|
Overall satisfaction with the intake of the preparation
Délai: week 2 (Colonoscopy visit)
|
Overall satisfaction with the intake of the preparation assessed with a numerical rating scale from 0=very bad to 10=very good (Tolerability and satisfaction questionnaire).
|
week 2 (Colonoscopy visit)
|
|
Endoscopist's satisfaction with the cleaning of faecal remains and bubbles
Délai: week 2 (Colonoscopy visit)
|
Endoscopist's satisfaction with the cleaning of faecal remains and bubbles, assessed with a numerical assessment scale from 0 = very dissatisfied to 10 = very satisfied (Data collection form).
|
week 2 (Colonoscopy visit)
|
|
Rate of adverse events
Délai: week 2 (Colonoscopy visit) and week 4 (visit 2)
|
Rate of adverse events including symptoms such as nausea, vomiting, abdominal pain, abdominal bloating, headache, chills, dizziness and dry mouth, which will be assessed in the Tolerability and Satisfaction Questionnaire (Tolerability and Satisfaction Questionnaire).
|
week 2 (Colonoscopy visit) and week 4 (visit 2)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
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 (Réel)
18 mai 2026
Achèvement primaire (Estimé)
1 mai 2028
Achèvement de l'étude (Estimé)
1 mai 2028
Dates d'inscription aux études
Première soumission
26 septembre 2025
Première soumission répondant aux critères de contrôle qualité
6 juillet 2026
Première publication (Réel)
10 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
10 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
6 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2025-523748-11-00
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
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .