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

The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease

Sponsors

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Collaborator: The Leona M. and Harry B. Helmsley Charitable Trust
University of Massachusetts, Worcester

Source Icahn School of Medicine at Mount Sinai
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.

Detailed Description

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 diet 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).

The goal of this study is to prospectively test the hypothesis that a non-invasive dietary intervention during the last trimester of pregnancy could beneficially shift the microbiome of CD patients and their babies, hereby promoting a healthier immune system during a critical time of the immune system development. Particularly, the study team will test whether favorable diet-driven changes in the microbiome can lead to a reduced risk of postpartum relapse and lower gut inflammation in the offspring.

Stool, saliva, breast milk and umbilical cord blood samples will be collected, and questionnaires administered. Self-selected participants to Arm 1 will adopt a specified diet, which will be adapted to address specific needs of third trimester pregnancy without compromising the diet principles. Subjects will receive nutritional counseling and training, and compliance to dietary recommendations will be recorded.

Analysis will be performed to correlate dietary change and assessed changes in quality of life with microbial composition in the gut and with circulating markers of inflammation in moms. The study team will also compare the effect of diet vs. non-diet on babies' microbiome and the impact of the early life microbiome in levels of inflammatory markers after 1-year of partum.

This study will help better understand the origin of the initial bacterial colonization in high-risk babies, providing potential intervention targets for primary CD prevention. The study team will also generate an extensive collection of serial samples and longitudinal clinical data, including identification of specific dietary components correlated with certain functional and quantitative bacterial patterns for future investigations. This study will help create new opportunities to foster a healthy microbiome in high risk babies of microbiome and immunity-mediated diseases, thereby hopefully reducing their risk later in life.

Overall Status Recruiting
Start Date January 30, 2019
Completion Date January 1, 2023
Primary Completion Date January 1, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in overall number of proteobacteria Baseline and 4 Years
Secondary Outcome
Measure Time Frame
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
The Bristol Stool Form Scale 4 Years
Alternative Healthy Eating Index 4 Years
Enrollment 396
Condition
Intervention

Intervention Type: Other

Intervention Name: Diet-CD

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

Arm Group Label: Diet-CD

Other Name: Diet Arm

Eligibility

Criteria:

Inclusion Criteria:

- Capacity to sign informed consent

- At least 18 years old

- Singleton pregnancy of less than 27-29 weeks gestation

- English-speaking

Exclusion Criteria:

- 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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Overall Contact

Last Name: Inga Peter, PhD

Phone: 212-659-8566

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator:
University of Massachusetts Medical School | Worcester, Massachusetts, 01655, United States Recruiting Barbara Olendzki, RD, MPH, LDN 650-880-1655 [email protected] Barbara Olendzki, RD, MPH, LDN Principal Investigator
Icahn School of Medicine at Mount Sinai | New York, New York, 10029, United States Recruiting Inga Peter, PhD 212-659-8566 [email protected] Inga Peter, PhD Principal Investigator
Location Countries

United States

Verification Date

June 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Diet-CD

Type: Experimental

Description: dietary intervention: 8-10 weeks of diet intervention

Label: No-Diet-CD

Type: No Intervention

Description: Usual diet with no intervention

Label: No-Diet-Control

Type: No Intervention

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

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: 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. Arm 1 (diet-CD): 8-10 weeks of dietary intervention (n=66) Arm 2 (no-diet-CD): usual diet with no intervention (n=66) Arm 3 (no-diet-control): unaffected controls at the same gestational stage will follow their usual diet and no intervention (n=66).

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov