Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders (COLIPRAL)
3. august 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
50
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Padova
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Padova, Padova, Italia, 35128
- Azienda Ospedale - Univeristà Padova
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Ta kontakt med:
- Fabiana Zingone
- Telefonnummer: +39 0498215656
- E-post: fabiana.zingone@unipd.it
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: 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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Placebo komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Microbiota gut composition
Tidsramme: 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 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).
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Fecal calprotectin levels
Tidsramme: 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
Tidsramme: 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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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. mars 2028
Studiet fullført (Antatt)
1. mars 2028
Datoer for studieregistrering
Først innsendt
29. juli 2026
Først innsendt som oppfylte QC-kriteriene
3. august 2026
Først lagt ut (Faktiske)
7. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. august 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 6576/AO/26
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Beginning 6 months after publication of the main results and ending 5 years thereafter.
Tilgangskriterier for IPD-deling
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.
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Nei
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