Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease (Butymixx)
Safety and Tolerability of Sodium Butyrate and Kluyveromyces Marxianus Supplementation in Inflammatory Bowel Disease Treatment
The goal of this clinical trial is to learn if a dietary supplement called ButyMixx can help people with ulcerative colitis in remission feel better and keep their intestines less inflamed.
ButyMixx contains:
- Sodium butyrate, a substance normally produced by our gut microbiota that helps protect the intestinal lining and reduce inflammation.
- A "beneficial" yeast (Kluyveromyces marxianus), similar to probiotics, which may support the balance of the intestinal microbiota.
It will also learn about the safety of dietary supplement. The main questions it aims to answer are:
Does ButyMixx after 2 months of supplementation
- Symptoms improve,
- Quality of life improves,
- Intestinal inflammation decreases ,
- The gut microbiota becomes more "balanced"
- What medical problems do participants have when taking ButyMixx ?
Participants will:
- Take 2 sachets of ButyMixx per day for 8 weeks
Before starting and at the end of the 8 weeks:
- Provide a stool sample
- Complete a quality-of-life questionnaire
- Be assessed by a doctor using a symptom score
연구 개요
상세 설명
ButyMixx Study A novel natural supportive strategy for Ulcerative Colitis in remission What is ulcerative colitis? Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by recurrent inflammation of the colonic mucosa, leading to symptoms such as diarrhea, rectal bleeding, abdominal pain, and fatigue.
Even during clinical remission, when symptoms are minimal or absent, the intestinal mucosa often remains fragile and susceptible to new inflammatory flares.
For this reason, current research is increasingly focused not only on treating acute disease activity, but also on identifying strategies able to maintain mucosal health over time, improve quality of life, and reduce the risk of relapse.
The role of the gut microbiota
The human gut hosts a complex community of microorganisms, known as the gut microbiota, which plays a crucial role in:
- digestion and nutrient metabolism
- protection against pathogenic microorganisms
- regulation of immune responses
- maintenance of intestinal barrier integrity In patients with UC, this microbial ecosystem is frequently altered (a condition known as dysbiosis), even during remission. Restoring a balanced microbiota is therefore considered a key therapeutic target.
What is ButyMixx?
ButyMixx is a dietary supplement combining two natural components:
Sodium butyrate
Butyrate is a short-chain fatty acid normally produced by bacterial fermentation of dietary fibers. It has several well-documented physiological functions:
- it is the main energy source for colonocytes
- supports epithelial repair and regeneration
- exerts anti-inflammatory effects
- contributes to the maintenance of intestinal barrier integrity In patients with UC, endogenous butyrate production is often reduced.
- Kluyveromyces marxianus
This is a probiotic yeast, commonly found in kefir, whose probiotic potential has been investigated in preclinical models. Studies have shown that K. marxianus:
- survives gastrointestinal transit efficiently
- interacts with the host immune system
- reduces pro-inflammatory signaling
- supports a more balanced intestinal microbiota It is recognized as safe by both European and US regulatory authorities.
Rationale of the study
The study was designed to investigate whether the combination of butyrate and probiotic yeast may represent a natural adjunctive strategy to standard pharmacological therapy (e.g., mesalamine and/or biologics), with the aim of:
- maintaining lower levels of intestinal inflammation
- improving patients' quality of life
- supporting gut microbiota homeostasis
- potentially reducing the risk of disease relapse
Study population
A total of 40 patients will be enrolled, meeting the following criteria:
- age between 18 and 75 years
- diagnosis of ulcerative colitis in clinical remission
- stable background medical therapy Patients with active disease, other forms of colitis, ongoing intestinal infections, pregnancy, or recent use of antibiotics/probiotics will be excluded.
Study design and procedures Study duration
- 8 weeks Supplement administration
- Two sachets of ButyMixx daily, taken before meals Study visits
Two visits are scheduled:
Baseline visit (T0)
- Clinical symptom assessment
- Quality-of-life questionnaire administration
Stool sample collection for:
- fecal calprotectin (marker of intestinal inflammation)
- gut microbiota analysis End-of-treatment visit (T1, after 8 weeks)
- Reassessment of symptoms and quality of life
- Repeat stool sample collection
- Recording of any adverse events
Study outcomes
The study aims to determine whether, after two months of supplementation:
- clinical symptoms improve
- quality of life increases
- intestinal inflammation decreases
- the gut microbiota shows a more balanced profile In parallel, the safety and tolerability of the supplement will be carefully evaluated.
Why is this study important?
If proven effective and safe, ButyMixx could become:
- a natural adjunct to pharmacological therapy
- a tool to support long-term intestinal health
- a strategy to reduce disease burden and improve daily well-being in patients with ulcerative colitis Contributing to a more comprehensive and preventive approach to disease management
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sonia Facchin
- 이메일: sonia.facchin@unipd.it
연구 연락처 백업
- 이름: Edoardo V Savarino
- 전화번호: 00390498127749
- 이메일: edoardo.savarinoi@unipd.it
연구 장소
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-
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Padova, 이탈리아, 352121
- 모병
- Edoardo Savarino
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연락하다:
- Edoardo Savarino
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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.
- Age between 18 and 75 years old
- Ability of subject to participate fully in all aspects of this clinical trial.
Exclusion Criteria:
- Patients that have active UC, determined by clinical, endoscopic and histopathological evidence
- Known diagnosis of CD( Crohn disease), indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis or microscopic colitis
- Positive stool culture for active C. difficile
- Pregnant women
- Patients under antibiotic and/or probiotic treatment within 10 days prior to Visit 1.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: Butimixx
single arm
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Patients will be treated with the ButyMixx , a stick pack probiotic supplement composed sodium butyrate and the yeast Kluyveromyces marxianus, as primary compounds (300 mg and 33.5 mg rispectively).Patients will be asked to take 2 stick packs per day, before meals for 8 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of the clinical effectiveness of ButyMixx
기간: 8 weeks
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The primary outcome is defined as the assessment of the clinical effectiveness of ButyMixx through a pre-post improvement (T0 vs T1) in at least one of the following three parameters: Partial Mayo Score (pMayo) - a clinical index measuring ulcerative colitis activity, including stool frequency, rectal bleeding, and physician's global assessment. IBDQ (Inflammatory Bowel Disease Questionnaire) - a validated questionnaire assessing disease-related quality of life. Fecal calprotectin (fCal) - an objective biomarker of intestinal inflammation. The primary outcome is therefore considered achieved if, after 8 weeks of supplementation, a clinically and statistically significant improvement is observed in at least one of these three indicators |
8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Safety and tolerability
기간: 8 weeks
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The secondary outcome is represented by the assessment of the safety and tolerability of the ButyMixx supplement. Systematic recording of adverse events (AEs) and serious adverse events (SAEs) All clinical events occurring during the study period are recorded according to standardized regulatory definitions and criteria. This allows assessment of whether ButyMixx intake is associated with undesirable effects and enables estimation of their frequency, type, and severity. Exploratory analysis of the intestinal microbiota Modulation of the microbiota profile is evaluated through 16S rRNA gene sequencing, and ITS(Internal Transcribed Spacer) sequencing for bacteria and fungi, with particular attention to the presence and dynamics of yeast species. This component is not intended as an efficacy endpoint, but rather as a tool to confirm that supplementation does not induce potentially unfavorable microbiological alterations, thereby strength |
8 weeks
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공동 작업자 및 조사자
수사관
- 수석 연구원: Edoardo V Savarino, Università degli Studi di Padova, DiSCOG
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- 6440/AO/25
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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