Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease

NCT03850600 | Active Not Recruiting

• 1 other identifier: GCO 18-2246
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 2

Brief Summary

The MELODY Trial: Modulating Early Life Microbiome through Dietary Intervention in Crohn's Disease, will test whether a non-invasive dietary intervention during pregnancy can improve the gut microbiota composition in both pregnant Crohn's disease patients and their babies during the sensitive time window of infant immune system development, and whether this can lead to decreased risk of maternal disease relapse postpartum and decreased functional gastrointestinal disorders and gut inflammation in their babies. Through this trial, the study team hopes to better understand the origin of the initial gut bacterial colonization in babies, providing potential intervention targets to prevent Crohn's disease development in high risk individuals.

Conditions

Crohn Disease; Pregnancy

Keywords

Microbiota; Diet; Immune System

Outcome Measures

Primary Outcomes (1)

• Change in overall number of proteobacteria

  Change in overall number of proteobacteria in pregnant CD patients at 4 years as compared to baseline

  Baseline and 4 Years

Secondary Outcomes (7)

• Calprotectin level

  4 Years

• Harvey Bradshaw index (HBI)

  4 Years

• SF-12

  4 Years

• The Rome IV Criteria

  3 months

• The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R)

  4 Years

Study Arms (3)

Diet-CD

EXPERIMENTAL

dietary intervention: 8-10 weeks of diet intervention

Other: Diet-CD

No-Diet-CD

NO INTERVENTION

Usual diet with no intervention

No-Diet-Control

NO INTERVENTION

Unaffected controls at the same gestational stage will follow usual diet and no intervention

Interventions

Diet-CD OTHER

CD patients will self-select into the intervention arm to follow the diet for 8-10 weeks during their third trimester of pregnancy.

Also known as: Diet Arm

Diet-CD

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capacity to sign informed consent
• At least 18 years old
• Singleton pregnancy of less than 27-29 weeks gestation
• English-speaking

You may not qualify if:

• Inability to provide informed consent
• HIV/AIDS
• Multi-fetus pregnancy
• Fetal chromosomal or structural abnormalities
• Active infection (including chorioamnionitis or sepsis)
• Alcohol use disorder
• Diagnosis of diabetes, renal disease, or intrauterine growth restriction
• Non-English speaking
• Active perianal or extraintestinal disease
• Antibiotic or steroid treatment at recruitment
• Scheduled cesarean section prior to gestational week 37

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• The Leona M. and Harry B. Helmsley Charitable Trust: collaborator
• University of Massachusetts, Worcester: collaborator

Study Sites (2)

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Inga Peter, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Barbara Olendzki, RD,MPH, LDN

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

• Ana Maldonado-Contreras, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study design is a three-arm, prospective, pre-post intervention trial. Crohn's Disease (CD) patients at 27-29 weeks of pregnancy will self-select to Arm 1 or Arm 2. Controls will be in Arm 3. 1. Arm 1 (diet-CD): 8-10 weeks of dietary intervention (n=66) 2. Arm 2 (no-diet-CD): usual diet with no intervention (n=66) 3. Arm 3 (no-diet-control): unaffected controls at the same gestational stage will follow their usual diet and no intervention (n=66).

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 22, 2019
• Study Start: January 30, 2019
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)