Fiber and anthocyanin complexes as direct modifiers of microbial dysbiosis in pediatric ulcerative colitis
Study on Fiber and Anthocyanin Complexes for Gut Health in Children with Ulcerative Colitis
Tina Zhang
Primary Investigator
Brief description of study
The study objective is to identify fiber combinations and fiber-anthocyanin complexes which support a broad spectrum of beneficial microbes which enhance fiber fermentation and increase Short Chain Fatty Acid production therefore promoting gut health with decreased inflammation and systemic benefits.
Detailed description of study
Participants will be randomly enrolled into one of two groups, Fiber Mix or Complex Mix, and begin control fiber supplement. Participants will be blinded as to whether participants are receiving supplement vs control in treatment period 1 or 2.
Aim 1. Design a prebiotic fiber mix and fiber mix+anthocyanin complex to enhance in vitro butyrate production in the presence of UC-associated bacterial dysbiosis. Pediatric patients with UC, receiving care within the Indiana University Riley Children’s Hospital for ulcerative colitis, will be identified under existing Pediatric Inflammatory Bowel Disease IRB#: (1011003811) for potential study participation.
Baseline stool samples from 4 donors will be used for in vitro fermentation studies (under Pediatric IBD Biorepository IRB # 25862).
Aim 2. Determine the effectiveness of the fiber mix and fiber mix-anthocyanin complex in enhancing butyrate production and microbial diversity in children with UC.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Ulcerative Colitis, Riley
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Age: 12 years - 20 years
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Gender: All
Inclusion Criteria:
• Age 12 through 20 at time of study visit 1
• Diagnosis of ulcerative colitis, based on endoscopic, histologic, and/or radiographic results, and per clinician assessment
• Clinical remission with Pediatric Ulcerative Colitis Activity Index less than 30 at time of study visit 1
Exclusion Criteria:
• Diagnosis of Crohn’s disease or indeterminant colitis
• Concomitant diagnosis of severe malnutrition
• Recent gastrointestinal infection with documented positive infectious etiology or requiring
treatment with antibiotics within 4 weeks prior to study visit 1
• Hospitalization for UC-related symptoms within 4 weeks prior to study visit 1
• Change in ulcerative colitis therapy within 8 weeks prior to study visit 1
• Use of corticosteroids (to include budesonide, prednisone, methylprednisolone, in IV,
enteral, and topical formulations) within 8 weeks prior to study visit 1
• Known allergy to fiber/complex components (pectin, blueberry)
This study investigates the effects of fiber and anthocyanin complexes on microbial imbalance, known as dysbiosis, in children with ulcerative colitis (UC). Ulcerative colitis is a condition where inflammation causes sores in the digestive tract, affecting the colon. The purpose is to find combinations that support beneficial gut microbes, enhance fiber fermentation, and increase short chain fatty acid production, which are important for maintaining gut health and reducing inflammation.
Participants will be divided into two study arms: Fiber Mix and Complex Mix. They will receive either a control fiber supplement or the investigational fiber supplement. The study uses a blinded approach, meaning participants will not know which supplement they are receiving during each treatment period. Baseline stool samples from donors will be used for in vitro studies to understand the fermentation process.
- Who can participate: Participants aged 12 to 20 with ulcerative colitis in clinical remission can join. They must not have Crohn's disease, severe malnutrition, or recent infections or hospitalizations related to UC.
- Study details: Participants will take either a fiber mix or a fiber-anthocyanin complex. The study is blinded, so participants will not know which supplement they receive.
