Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome
NCT ID: NCT06162143
Last Updated: 2024-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
73 participants
OBSERVATIONAL
2023-11-15
2025-11-15
Brief Summary
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Detailed Description
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The objective of this study is to provide preliminary data to determine whether the administration of Gelsectan® may ameliorate the symptoms of LARS.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Gelsectan®
Patients in the Gelsectan® cohort will receive one capsule of Gelsectan® twice a day (after lunch and dinner) for 28 days.
Gelsectan®
Gelsectan® is a CE-marked class II device containing xyloglucans, xylo-oligosaccharides, pea proteins, and tannins from grape seeds extract, already used in Irritable Bowel Syndrome (IBS).
Interventions
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Gelsectan®
Gelsectan® is a CE-marked class II device containing xyloglucans, xylo-oligosaccharides, pea proteins, and tannins from grape seeds extract, already used in Irritable Bowel Syndrome (IBS).
Eligibility Criteria
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Inclusion Criteria
* Patients who underwent low rectal resection for rectal cancer and who closed the ileostomy at least three months before the screening visit.
* Patients with a LARS score ≥21 and/or clinically relevant symptoms of urgency, increased stool frequency, or fecal incontinence.
* Patients indicated to treatment with Gelsectan® according to the clinical judgment.
* Oncological chemotherapy or radiotherapy completed at least four weeks before the screening visit.
* Presence of a functional, intact anastomosis.
* Female patients of childbearing potential must agree to use a reliable method of contraception.
Exclusion Criteria
* Any condition that, in the opinion of the investigator, may interfere with the study procedures.
* Significant anastomotic complications (e.g., strictures, fistula), which may impair the treatment efficacy.
* Pregnant or breastfeeding women.
* Inability to comply with the study procedures.
18 Years
ALL
No
Sponsors
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Istituto Clinico Humanitas
OTHER
Responsible Party
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Principal Investigators
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Antonino Spinelli, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Humanitas Research Hospital IRCCS, Rozzano-Milan
Locations
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IRCCS Humanitas Research Hospital
Rozzano, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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097-2022
Identifier Type: -
Identifier Source: org_study_id
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