Non-nutritive Sweeteners in Inflammatory Bowel Disease
The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease
연구 개요
상세 설명
Participation in this study will last for a minimum of 35 days (Phase I: 14-days; baseline with removal of all NNS (eg saccharin, sucralose, steviosides, aspartame, acesulfame-k, erythritol) from the diet, Phase II: 21-days; sucralose intervention, and will involve one virtual visit (study visit 1) and two in-person study visits (study visit 2 and study visit 3).
Fecal & urine samples will be collected before/after each phase. Blood will also be collected.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Abigail Raffner, RD PhD
- 전화번호: 216-327-6003
- 이메일: Abigail.Raffner@uhhospitals.org
연구 연락처 백업
- 이름: Sargun Singh, M.B.B.S.
- 전화번호: 216-333-6085
- 이메일: sargun.singh@uhhospitals.org
연구 장소
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Ohio
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Chagrin Falls, Ohio, 미국, 44122
- 모병
- UH Minoff Health Center
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부수사관:
- Jeffry Katz, MD
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연락하다:
- Abigail Basson, RD PhD
- 이메일: Abigail.Basson@uhhospitals.org
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Cleveland, Ohio, 미국, 44106
- 모병
- University Hospitals Cleveland Medical Center
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부수사관:
- Jeffry Katz, MD
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연락하다:
- Abigail Basson, RD PhD
- 이메일: Abigail.Basson@uhhospitals.org
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부수사관:
- Vu Nguyen, MD
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Westlake, Ohio, 미국, 44145
- 모병
- UH Westlake Health Center
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연락하다:
- Abigail Basson, RD PhD
- 이메일: Abigail.Basson@uhhospitals.org
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부수사관:
- Vu Nguyen, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
Age range from: 18 to 70 years. Male or female. Documented diagnosis of Crohns disease. CD outpatients in remission; Harvey Bradshaw- index in remission (<6 score).
Capable of providing consent to participate. Able to complete daily surveys and take oral nutrition. Able to record meal intake. Healthy controls with no diagnosis of IBD or Irritable Bowel Syndrome (IBS).
Exclusion Criteria:
Short bowel syndrome. Hospitalized patients. Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.
Known drug abuse. Known parasitic disease of the digestive system. Symptomatic intestinal stricture/narrowing. Presence of an ostomy. Known active malignancy. Antibiotic use within last 14 days. Well-founded doubt about the patients cooperation. Existing pregnancy or lactation. History of <1 natural bowel movements per 3 consecutive days. Unable to access to technology that permits the daily completion of study related activities.
Change in IBD medication within past 4 weeks. Body mass Index <18 kg/m or ≥35 kg/m. Documented C.difficile colitis within four weeks of screening. Bariatric surgery Phenylketonuria
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Crohn's participants
Crohn's participants will consume artificial sweetener: sucralose
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Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg.
This dose is below the acceptable daily intakes (ADI) of 5mg/kg.
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실험적: Healthy Controls
Healthy control participants will consume artificial sweetener: sucralose
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Participants will consume 2 sachets/day during the exposure period resulting in the following daily dose: sucralose 2.5mg/kg.
This dose is below the acceptable daily intakes (ADI) of 5mg/kg.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in fecal microbiome measured by metagenome analysis
기간: Baseline, three weeks pre-intervention, and three weeks after intervention
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Quantify the change in the fecal microbiome using metagenome analysis
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Baseline, three weeks pre-intervention, and three weeks after intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Fecal Myeloperoxidase activity (MPO)
기간: Baseline, three weeks pre-intervention, three weeks post-intervention
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Quantify the change in fecal MPO
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Baseline, three weeks pre-intervention, three weeks post-intervention
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Change in Fecal Calprotectin
기간: Baseline, three weeks pre-intervention, three weeks post-intervention
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Quantify the change in fecal calprotectin
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Baseline, three weeks pre-intervention, three weeks post-intervention
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Change in Crohn's Disease Activity Index (CDAI)
기간: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
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Quantify the change in Crohn's Disease Activity Index.
The Crohn's Disease Activity Index (CDAI) is a validated clinical instrument used to quantify Crohn's disease activity.
It evaluates 8 components over a 7-day period: number of liquid or very soft stools, severity of abdominal pain, general well-being, extraintestinal complications, use of antidiarrheal medications, presence of an abdominal mass, hematocrit levels, and body weight deviation.
Each component is multiplied by a specific weighting factor and summed to calculate a total score.
Total scores range from 0 to approximately 600 points, where lower scores indicate lower disease activity.
A score of <150 indicates clinical remission, while a score of >450 indicates severe disease.
A negative change from baseline indicates clinical improvement.
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Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention)
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Change in C-reactive protein (CRP)
기간: Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
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Quantify change in CRP
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Study visit 2 (three weeks pre-intervention) & 3 (three weeks post-intervention_
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공동 작업자 및 조사자
수사관
- 수석 연구원: Fabio Cominelli, MD PhD, University Hospitals Cleveland Medical Center
- 수석 연구원: Abigail Raffner, RD PhD, Case Western Reserve University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
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