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Assessment of the Efficacy of E. Coli 5C in the Management of Post-Colonoscopy Symptoms

6 november 2026 bijgewerkt door: Dr. Amjad Khan, Liaquat University of Medical & Health Sciences

Assessment of the Efficacy of E. Coli 5C in the Management of Post-colonoscopy Symptoms: a Randomised, Double-blind, Placebo-controlled Trial.

This prospective, randomized, double-blind, placebo-controlled clinical trial will evaluate the efficacy and safety of Escherichia coli 5C (Colipral®) in adult patients undergoing diagnostic colonoscopy. Participants will be randomized in a 1:1 ratio to receive either Colipral® or placebo for 14 days immediately after colonoscopy. The study aims to determine whether Colipral® reduces post-colonoscopy gastrointestinal symptoms compared with placebo, using validated symptom and stool assessment tools, patient-reported global improvement, and safety monitoring.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Patients undergoing diagnostic colonoscopy may experience gastrointestinal discomfort in the days following the procedure, which may be related to alterations in the intestinal microbiota induced by bowel preparation. This study is designed to evaluate whether supplementation with Escherichia coli 5C (Colipral®) can reduce post-colonoscopy gastrointestinal symptoms compared with placebo.

This is a prospective, randomized, double-blind, placebo-controlled clinical trial. Adult patients undergoing complete diagnostic colonoscopy will be screened according to predefined inclusion and exclusion criteria and enrolled after written informed consent. Participants will be randomly assigned in a 1:1 ratio to receive either Colipral® or placebo for 14 days immediately following colonoscopy. The study treatment will be administered as 2 capsules per day, with 1 capsule in the morning and 1 capsule in the evening after dinner.

Clinical assessments will be performed at baseline and at 48 hours, 7 days, and 14 days after colonoscopy, with patient global impression of change and clinically relevant improvement assessed only at Day 7 and Day 14. The primary efficacy endpoint is the between-group difference in change in Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline to Day 14. Secondary assessments include numerical rating scale (NRS) symptom scores, stool consistency, bowel movement frequency, patient global impression of change, clinically relevant improvement in gastrointestinal symptoms, use of rescue medication, treatment adherence, tolerability, and adverse events.

The study is designed to assess both the clinical efficacy and safety of Colipral® in the management of post-colonoscopy symptoms in adult patients.

Studietype

Ingrijpend

Inschrijving (Geschat)

160

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Italië
      • Roma, Italië, 00191
        • Clinica ARS Biomedica - Via Luigi Bodio 58
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Aged between 18 and 80 years;
  • Must have undergone a full colonoscopy on the date of enrolment.

Exclusion Criteria:

  • Chronic Inflammatory Bowel Disease
  • Complicated Diverticular Disease (DICA classification >3)
  • Neoplastic disease of the colon
  • Diagnosed microscopic colitis
  • Therapeutic colonoscopy
  • Immunocompromised patients (primary immunodeficiency, cancer undergoing active chemotherapy or immunotherapy, autoimmune disease undergoing immunosuppressive treatment)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Escherichia coli 5C (Colipral®)

Participants in this arm will receive Colipral® (dietary supplement containing Escherichia coli 5C), administered twice daily, with 1 capsule in the morning and 1 capsule in the evening after dinner, for 14 days immediately following colonoscopy.
Voedingssupplement: Colipral®

Dietary supplement containing Escherichia coli 5C (Colipral®)
Placebo-vergelijker: Placebo

Participants in this arm will receive placebo, identical in appearance but not containing the probiotic strain, administered twice daily, with 1 capsule in the morning and 1 capsule in the evening after dinner, for 14 days immediately following colonoscopy.
Ander: Placebo

Matching placebo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Gastrointestinal Symptom Rating Scale (GSRS) total score at Day 14
Tijdsspanne: Baseline to Day 14 after colonoscopy

Between-group difference in change in gastrointestinal symptom severity from baseline to Day 14 after colonoscopy, assessed using the Gastrointestinal Symptom Rating Scale (GSRS).
Baseline to Day 14 after colonoscopy

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in abdominal pain intensity score
Tijdsspanne: 48 hours, Day 7, and Day 14 after colonoscopy

Between-group difference in abdominal pain intensity assessed using a Numerical Rating Scale (NRS, 0-10), with higher scores indicating greater symptom intensity, at 48 hours, Day 7, and Day 14 after colonoscopy.
48 hours, Day 7, and Day 14 after colonoscopy
Change in abdominal bloating intensity score
Tijdsspanne: 48 hours, Day 7, and Day 14 after colonoscopy

Between-group difference in abdominal bloating intensity assessed using a Numerical Rating Scale (NRS, 0-10), with higher scores indicating greater symptom intensity, at 48 hours, Day 7, and Day 14 after colonoscopy.
48 hours, Day 7, and Day 14 after colonoscopy
Change in flatulence intensity score
Tijdsspanne: 48 hours, Day 7, and Day 14 after colonoscopy

Between-group difference in flatulence intensity assessed using a Numerical Rating Scale (NRS, 0-10), with higher scores indicating greater symptom intensity, at 48 hours, Day 7, and Day 14 after colonoscopy.
48 hours, Day 7, and Day 14 after colonoscopy
Change in stool consistency assessed by Bristol Stool Form Scale
Tijdsspanne: 48 hours, Day 7, and Day 14 after colonoscopy

Between-group difference in stool consistency assessed using the Bristol Stool Form Scale at 48 hours, Day 7, and Day 14 after colonoscopy.
48 hours, Day 7, and Day 14 after colonoscopy
Change in frequency of bowel movements
Tijdsspanne: 48 hours, Day 7, and Day 14 after colonoscopy

Between-group difference in the mean number of daily bowel movements recorded at 48 hours, Day 7, and Day 14 after colonoscopy.
48 hours, Day 7, and Day 14 after colonoscopy
Global Assessment of Change of Gastrointestinal Symptoms (PGIC) score at Day 7 and Day 14
Tijdsspanne: Day 7 and Day 14 after colonoscopy

Between-group difference in the Global Assessment of Change of Gastrointestinal Symptoms at Day 7 and Day 14, measured using the Patient Global Impression of Change (PGIC), a 7-category ordinal scale ranging from "Very much worse" to "Very much improved".
Day 7 and Day 14 after colonoscopy
Proportion of participants with clinically relevant improvement in gastrointestinal symptoms
Tijdsspanne: Day 7 and Day 14 after colonoscopy

Proportion of participants with clinically relevant improvement in gastrointestinal symptoms, defined as a PGIC response of "Improved", assessed at Day 7 and Day 14 after colonoscopy.
Day 7 and Day 14 after colonoscopy
Use of rescue medication for gastrointestinal symptoms
Tijdsspanne: Within 14 days after colonoscopy

Proportion of participants who used concomitant or rescue medication for control of gastrointestinal symptoms within 14 days after colonoscopy. Type of drug, days of intake, and dose will also be recorded.
Within 14 days after colonoscopy
Frequency of adverse events
Tijdsspanne: Within 14 days after colonoscopy

Frequency and type of adverse events reported within 14 days after colonoscopy, including suspected allergic symptoms, nausea, vomiting, and other clinically relevant events.
Within 14 days after colonoscopy
Treatment tolerability score
Tijdsspanne: Day 14 after colonoscopy

Treatment tolerability assessed using a numerical score from 0 to 10 during the 14-day post-colonoscopy period.
Day 14 after colonoscopy
Adherence to treatment
Tijdsspanne: Within 14 days after colonoscopy

Adherence to study treatment, expressed as the percentage of doses taken compared with those expected during the 14-day observation period.
Within 14 days after colonoscopy

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Liaquat University of Medical & Health Sciences

Medewerkers

University of Urbino "Carlo Bo"

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

16 november 2026

Primaire voltooiing (Geschat)

30 april 2027

Studie voltooiing (Geschat)

30 april 2027

Studieregistratiedata

Eerst ingediend

6 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

6 november 2026

Eerst geplaatst (Werkelijk)

12 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

6 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 139_16luglio2025_COLIPRAL_SIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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