Efficacy and Tolerability of a Simethicone-containing Evacuating Solution for Colorectal Cancer Screening Colonoscopy (CLEAN+)
6 juli 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
818
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Maria Pellisé
- Telefonnummer: +34 932275400
- E-post: MPELLISE@clinic.cat
Studera Kontakt Backup
- Namn: Judit Pich
- Telefonnummer: 2815 +34 932275400
- E-post: JPICH@recerca.clinic.cat
Studieorter
-
-
Barcelona
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Barcelona, Barcelona, Spanien, 08036
- Rekrytering
- Hospital Clinic de Barcelona
-
Huvudutredare:
- Maria Pellisé
-
Kontakt:
- Maria Pellisé
- E-post: MPELLISE@clinic.cat
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
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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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Adenoma detection rate
Tidsram: week 2 (Colonoscopy visit)
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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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Lesion detection rate
Tidsram: 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.
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week 2 (Colonoscopy visit)
|
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Adenomas per colonoscopy
Tidsram: week 2 (Colonoscopy visit)
|
Adenomas per colonoscopy, defined as the mean number of adenomas detected by colonoscopy in the subjects in each group.
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week 2 (Colonoscopy visit)
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Presence of foam
Tidsram: week 2 (Colonoscopy visit)
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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).
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week 2 (Colonoscopy visit)
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Presence of bubbles
Tidsram: week 2 (Colonoscopy visit)
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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).
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week 2 (Colonoscopy visit)
|
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Quality of colon cleansing
Tidsram: 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)
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Need for washing tools during colonoscopy
Tidsram: week 2 (Colonoscopy visit)
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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.
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week 2 (Colonoscopy visit)
|
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Cecal intubation rate
Tidsram: week 2 (Colonoscopy visit)
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Cecal intubation rate.
The colonoscopy will be considered complete if the cecum has been reached; otherwise, it will be considered incomplete.
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week 2 (Colonoscopy visit)
|
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Cecal intubation time
Tidsram: week 2 (Colonoscopy visit)
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Cecal intubation time.
Defined as the time elapsed between the introduction of the endoscope and reaching the cecal fundus.
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week 2 (Colonoscopy visit)
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Endoscope removal time
Tidsram: week 2 (Colonoscopy visit)
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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.
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week 2 (Colonoscopy visit)
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Requires repeat colonoscopy due to poor preparation
Tidsram: 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
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week 2 (Colonoscopy visit)
|
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Adherence to the intake of the preparation
Tidsram: week 2 (Colonoscopy visit)
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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).
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week 2 (Colonoscopy visit)
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Ease of taking the preparation
Tidsram: 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).
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week 2 (Colonoscopy visit)
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Palatability of the preparation
Tidsram: week 2 (Colonoscopy visit)
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Palatability of the preparation assessed with a numerical assessment scale from 0=very bad to 10=excellent (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
|
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Willingness to repeat the intake of the preparation
Tidsram: week 2 (Colonoscopy visit)
|
Willingness to repeat the intake of the preparation assessed as yes or no (Tolerability and satisfaction questionnaire).
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week 2 (Colonoscopy visit)
|
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Overall satisfaction with the intake of the preparation
Tidsram: week 2 (Colonoscopy visit)
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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).
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week 2 (Colonoscopy visit)
|
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Endoscopist's satisfaction with the cleaning of faecal remains and bubbles
Tidsram: week 2 (Colonoscopy visit)
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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).
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week 2 (Colonoscopy visit)
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Rate of adverse events
Tidsram: week 2 (Colonoscopy visit) and week 4 (visit 2)
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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).
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week 2 (Colonoscopy visit) and week 4 (visit 2)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 maj 2026
Primärt slutförande (Beräknad)
1 maj 2028
Avslutad studie (Beräknad)
1 maj 2028
Studieregistreringsdatum
Först inskickad
26 september 2025
Först inskickad som uppfyllde QC-kriterierna
6 juli 2026
Första postat (Faktisk)
10 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2025-523748-11-00
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