Evaluation of the Effects of Colipral on Microbiota Gut Composition in Patients Presenting With Ulcerative Colitis During Remission Phase and Functional Disorders (COLIPRAL)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Padova
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Padova, Padova, 이탈리아, 35128
- Azienda Ospedale - Univeristà Padova
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연락하다:
- Fabiana Zingone
- 전화번호: +39 0498215656
- 이메일: fabiana.zingone@unipd.it
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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건강 보조 식품: Food Supplement Colipral in film-coated tablets containing Escherichia coli 5C LMG S-33222
2 tablets/day of Colipral (1/breakfast, and 1/dinner, before the meal) for 60 days
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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Microbiota gut composition
기간: 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.
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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).
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Fecal calprotectin levels
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 6576/AO/26
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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