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临床试验/NCT07118657
NCT07118657招募中不适用

Host-Diet-Gut Interaction Post Vegan Diet in Pediatric Autoimmune Hepatitis.

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Proportion of patients achieving biochemical remission after 180 days of vegan and standard high protein diet in treatment naive pediatric subjects with autoimmune hepatitis.

研究概览

简要总结

Pediatric autoimmune liver diseases (AILDs), including autoimmune hepatitis (AIH) and overlap syndromes like sclerosing cholangitis, are among the most common chronic liver conditions in the pediatric population. Currently, the treatment for AIH often involves long-term use of immunosuppressive therapy, which carries risks of severe side effects both in the short and long term. Due to these potential adverse effects, there is a critical need to explore alternative therapies that can modulate autoimmunity and potentially reduce or eliminate the dependence on immunosuppressive drugs. Autoimmune diseases, including AIH, typically arise in genetically predisposed individuals after exposure to certain environmental factors, leading to a breakdown in self-tolerance.The gut microbiome plays a crucial role in modulating the immune system through both anti-inflammatory and pro-inflammatory pathways. In advanced liver diseases, factors such as intestinal dysmotility, small intestinal bacterial overgrowth (SIBO), and increased intestinal permeability contribute to enhanced bacterial translocation, consistent with the "leaky gut" hypothesis. This phenomenon allows the passage of toxins, antigens, and bacteria into the systemic circulation, potentially exacerbating autoimmune responses. Consequently, altering the gut microbiome through dietary changes, probiotics, prebiotics, or fecal microbiota transplantation presents a promising therapeutic approach for autoimmune diseases.This study aims to investigate the gut microbiome and its modification following dietary intervention (specifically, a plant-based vegan diet) in pediatric AIH. Additionally, investigator will explore the potential role of such interventions in managing intestinal dysfunction in patients with advanced liver disease. In Aim 1, investigator will compare the baseline gut microbiome profiles of treatment-naïve pediatric AIH patients with those of healthy, age- and sex-matched controls to provide foundational insights. In Aim 2, investigator will evaluate the proportion of patients achieving biochemical remission after 180 days of a vegan versus standard diet in AIH patients. Investigator will also assess changes in stool metagenomics, metabolomics, cytokine profiles, gut epithelial barrier function, and liver disease severity scores between the two dietary groups.

This study aims to demonstrate the potential benefits of a vegan diet in managing autoimmune hepatitis. It seeks to provide evidence supporting dietary modifications as a complementary approach to standard medical treatments for a wide range of autoimmune or autoimmune-like disorders, potentially paving the way for future therapeutic strategies.

详细描述

Hypothesis/Research Question:

  1. P = Population/Patient/Problem - Pediatric patients (< 18 years of age) with Autoimmune Hepatitis
  2. I = Intervention -Vegan diet for 180 days (in addition of standard immunosuppressive medical therapy)
  3. C = Comparison - Standard High Protein diet for 180 days (in addition of standard immunosuppressivemedical therapy)
  4. O = Outcome - Proportion of subjects achieving biochemical remission; change in stool metagenome/metabolome/cytokines, gut epithelial barrier function, and liver disease severity scores between the two study groups.

Methodology:

Place: Department of Pediatric Hepatology &Molecular and Cellular Medicine, Institute of Liver and Biliary Sciences, New Delhi

  • Study design: Prospective, Randomized, Single center, Open label study
  • Study period: October 2024 to October 2027 Details of the diets (Vegan diet and Standard High Protein diet) Vegan diet would be defined as a diet based solely of plant products with exclusion of all animal products including meat, fish, dairy, honey and eggs.
  • Additional supplementation of vitamin B12 (500 µg/day) in the vegan diet group along with calcium (50-75 mg/kg/day), vitamin D (800-1600 IU/day) and iron supplementation (3-6 mg/kg/day) as per requirement.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
0 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Cases diagnosed as Autoimmune hepatitis (AIH).
  • •Controls are healthy subjects.

排除标准

  • •Recent (< 6 weeks) exposure to oral or intravenous antibiotics, probiotics/prebiotics, proton pump inhibitors, or herbal medicines.
  • •Any history of malignancy or any gastrointestinal tract surgery.
  • •Recent (< 2 weeks) gastrointestinal infection.
  • •Any dietary allergies .

研究组 & 干预措施

Standard Diet

Active Comparator

干预措施: Standard Diet (Other)

Vegan Diet

Experimental

干预措施: Vegan Diet (Other)

结局指标

主要结局

Proportion of patients achieving biochemical remission after 180 days of vegan and standard high protein diet in treatment naive pediatric subjects with autoimmune hepatitis.

时间窗: 180 days

biochemical remission is defined as normalization of both serum AST/ALT \& serum IgG. high protein (2-3 g/kg/day)

次要结局

  • Change in stool & blood cytokines (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).(180 days)
  • Change in stool metagenome (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).(180 days)
  • Change in liver disease severity score (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).(180 days)
  • Change in stool metabolome (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).(180 days)
  • Change in blood flow cytometry (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).(180 days)
  • Change in Gut Epithelial Barrier Function (after 180 daysof plant based (vegan) vs. standard high protein diet along with standard medical management including immunosuppression in treatment naive pediatric subjects with autoimmune hepatitis).(180 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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