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

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ClinicalTrials.gov Identifier: NCT03850600
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : October 1, 2020
Sponsor:
Collaborators:
The Leona M. and Harry B. Helmsley Charitable Trust
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Inga Peter, 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Pregnancy Other: Diet-CD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 396 participants
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.

  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).
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The MELODY Trial: Modulating Early Life Microbiome Through Dietary Intervention in Crohn's Disease
Actual Study Start Date : January 30, 2019
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Diet-CD
dietary intervention: 8-10 weeks of diet intervention
Other: Diet-CD
CD patients will self-select into the intervention arm to follow the diet for 8-10 weeks during their third trimester of pregnancy.
Other Name: Diet Arm

No Intervention: No-Diet-CD
Usual diet with no intervention
No Intervention: No-Diet-Control
Unaffected controls at the same gestational stage will follow usual diet and no intervention



Primary Outcome Measures :
  1. Change in overall number of proteobacteria [ Time Frame: Baseline and 4 Years ]
    Change in overall number of proteobacteria in pregnant CD patients at 4 years as compared to baseline


Secondary Outcome Measures :
  1. Calprotectin level [ Time Frame: 4 Years ]
    Calprotectin is a stool marker of inflammation

  2. Harvey Bradshaw index (HBI) [ Time Frame: 4 Years ]
    Assessments of CD symptom severity

  3. SF-12 [ Time Frame: 4 Years ]

    Quality of life will be assessed using the SF-12.

    Mental and physical functioning is assessed by the Medical Outcomes Study Short Form 12 (SF-12) Health Survey. The questions in the SF-12 target eight dimensions of health and are weighted and summed to provide two composite measures, the Physical Composite Scale and Mental Composite Scale (PCS and MCS). The PCS and MCS are scored to range from 0 to 100, with 0 indicating the lowest level of health and 100 indicating the highest level of health.


  4. The Rome IV Criteria [ Time Frame: 3 months ]
    The Rome IV Criteria for Functional Gastrointestinal Disorders in Infants will be used to assess infant's functional gastrointestinal disorders at 3 months of age. The Rome IV is a validated diagnostic criteria used to improve clinical care in infants and toddlers, adequately diagnose functional gastrointestinal disorders in order to provide proper treatment, and improve homogeneity in research study design.

  5. The Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) [ Time Frame: 4 Years ]

    The CES-D is a 20-item measure assessing symptoms of depression based on a 4-point Likert scale ranging from 0 -3, with higher score indicating more depression.

    and depressive disorder. The symptoms it measures are those defined by the American Psychiatric Association Diagnostic and Statistical Manual (DSM-V) for a major depressive episode.


  6. The Bristol Stool Form Scale [ Time Frame: 4 Years ]
    A validated 7 point scale used extensively in clinical practice and research for classification of stool form. The scale is from 1-7 and a higher score indicates looser stool. A score of 1 is classified as "separate hard lumps, like nuts (hard to pass), while a score of 7 is classified as "Watery, no solid pieces (entirely liquid)."

  7. Alternative Healthy Eating Index [ Time Frame: 4 Years ]
    Alternative Healthy Eating Index (AHEI) - total score ranging from 2.5 (least desirable) to 87.5 (most desirable) dietary pattern



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03850600


Contacts
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Contact: Inga Peter, PhD 212-659-8566 inga.peter@mssm.edu
Contact: Ryan Adams 212-659-6710 Ryan.adams@mountsinai.org

Locations
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United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Barbara Olendzki, RD, MPH, LDN    650-880-1655    melodytrialumass@gmail.com   
Contact: Ana Maldonado-Contreras, PhD    650-880-1655    melodytrialumass@gmail.com   
Principal Investigator: Barbara Olendzki, RD, MPH, LDN         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Inga Peter, PhD    212-659-8566    inga.peter@mssm.edu   
Contact: Ryan Adams    212-659-6710    Ryan.adams@mountsinai.org   
Principal Investigator: Inga Peter, PhD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
The Leona M. and Harry B. Helmsley Charitable Trust
University of Massachusetts, Worcester
Investigators
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Principal Investigator: 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
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Responsible Party: Inga Peter, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03850600    
Other Study ID Numbers: GCO 18-2246
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inga Peter, Icahn School of Medicine at Mount Sinai:
Microbiota
Diet
Immune System
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases