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Crohn DiseaseNCT03850600

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

A study testing Diet-CD in people with Crohn Disease and Pregnancy, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Crohn Disease, Pregnancy
What is being tested?
Diet-CD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
2 sitesUnited States
Study dates
30 Jan 2019to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Inability to provide informed consent
  • HIV/AIDS
  • Multi-fetus pregnancy
  • Fetal chromosomal or structural abnormalities
  • Active infection (including chorioamnionitis or sepsis)
  • Alcohol use disorder
Show all 11Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: The MELODY Trial: 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, 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.

Read the 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.

Being tested
Diet-CD
Keywords
Microbiota, Diet, Immune System
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diet-CDOther

    Also called Diet Arm

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

Study groups in NCT03850600
Study groupRoleWhat they receive
Diet-CDExperimentaldietary intervention: 8-10 weeks of diet intervention
Receives: Other: Diet-CD
No-Diet-CDNo interventionUsual diet with no intervention
No-Diet-ControlNo interventionUnaffected controls at the same gestational stage will follow usual diet and no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in overall number of proteobacteria

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

    Measured: Baseline and 4 Years

Secondary outcomes (7)

  1. Calprotectin level

    Calprotectin is a stool marker of inflammation

    Measured: 4 Years

  2. Harvey Bradshaw index (HBI)

    Assessments of CD symptom severity

    Measured: 4 Years

  3. SF-12

    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.

    Measured: 4 Years

  4. The Rome IV Criteria

    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.

    Measured: 3 months

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

    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.

    Measured: 4 Years

  6. The Bristol Stool Form Scale

    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)."

    Measured: 4 Years

  7. Alternative Healthy Eating Index

    Alternative Healthy Eating Index (AHEI) - total score ranging from 2.5 (least desirable) to 87.5 (most desirable) dietary pattern

    Measured: 4 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2019
  2. Study start30 Jan 2019
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03850600
Sponsor's protocol ID
GCO 18-2246
Status last verified
Nov 2024
First submitted
15 Feb 2019
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Diet-CD in people with Crohn Disease and Pregnancy, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in overall number of proteobacteria (time frame: Baseline and 4 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03850600.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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