- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07560176
Impact of Nutritional Managment on Pregnancy With IBD Patients and Their Springs (IBD/pregnancy)
Study Overview
Status
Conditions
Detailed Description
Pregnancy is a critical time for the intergenerational transmission of health (. Pregnant women with active inflammatory bowel disease (IBD), a chronic disease characterized by inflammation of the gastrointestinal tract are considered to be at higher risk of poor pregnancy outcomes such as preterm birth, low birthweight or small for gestational age (SGA), spontaneous abortion, and stillbirth, and comprise an increased percentage of Cesarean deliveries compared to women in remission or without IBD. The prevalence of IBD has been increasing worldwide; thus, improving the health of pregnant women with IBD is essential to decreasing their risk for adverse pregnancy outcomes.
A balanced perinatal diet can support optimal health for pregnant women and have a long-term impact on their offspring. Patients with IBD are already prone to nutrition deficiencies due to factors such as restrictive diets, nutrient loss, drug-nutrient interaction, and decreased absorption from the ileum. Furthermore, reduced oral intake and chronic inflammation increases nutrient needs among IBD patients. Two reports have explored the diets of pregnant women in the Norwegian Mother and Child Cohort (MoBa). The first study found that compared to pregnant women without IBD, pregnant women with IBD were less likely to adhere to a traditional Norwegian dietary pattern characterized by a high intake of lean fish or fish products, potatoes, rice porridge, cooked vegetables, and gravy, and were more likely to adhere to a Western dietary pattern with higher intake of foods and beverages rich in sugar and saturated fats. Moreover, pregnant women with IBD who did adhere to the traditional Norwegian diet had lower odds of having an SGA infant. The second study found that pregnant women with IBD consumed a lower proportion of protein from dairy products compared to pregnant women without IBD. In this case, a reduced intake of protein from dairy was associated with a lower risk of having an SGA infant.
Maternal diet during pregnancy has also been linked to the infant microbiome composition, which is critical for the priming of a balanced immune system during early life. Importantly, it was demonstrated that infants born to women with IBD have less diverse microbiomes and higher levels of fecal calprotectin (a biomarker of intestinal inflammation) compared to the infants of women without IBD. Along with emerging reports demonstrating the mediating role of the gut microbiota in the effectiveness of dietary interventions for IBD management, this finding suggests that improving dietary patterns during pregnancy may beneficially modify the microbiome composition, thereby promoting both maternal and infant health. This hypothesis is being explored by the MELODY (Modulating Early Life Microbiome through Dietary Intervention in Pregnancy) Trial Diet has been increasingly integrated into IBD management, and studies demonstrate the effectiveness of dietary interventions for inducing IBD remission. In adults, the specific carbohydrate diet (SCD); the Mediterranean diet; the low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (low FODMAP) diet; and the anti-inflammatory IBD (IBD-AID) diet are among those that have shown efficacy in reducing disease activity and symptoms. Yet, informational resources on nutrition for pregnant women with IBD are sparse. The USDA MyPlate website focuses on a variety of food groups with only broad suggestions of foods and meal plans specific to pregnancy and postpartum needs. The 2014 and 2017 American College of Obstetricians and Gynecologists (ACOG) guideline statements seem focused on nutrients that may be obtained by taking a prenatal vitamin, rather than on whole foods. The 2019 American Gastroenterological Association's Inflammatory Bowel Disease in Pregnancy Clinical Care Pathway report encourages nutrition consultation for specific nutrient deficiency and weight gain patterns in this population, but with few details on compliance to guidelines. In keeping with these publications, pregnant women may hear only general advice from health care providers to take a prenatal vitamin, follow a healthy diet, limit caffeine intake, avoid alcohol and tobacco, and observe caution with seafood. However, while a prenatal vitamin may be recommended in addition to a healthy diet, it cannot supply all the nutrients that are needed to promote healthy and low-risk pregnancies.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amira Mohamed Abdelmawgod, MD
- Phone Number: 01012760437
- Email: amiramohmad60@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Patients underwent clinical, laboratory, endoscopic, and/or imaging evaluations as part of routine outpatient monitoring.
- Laboratory investigations (Complete blood picture, Liver function tests, C-reactive protein and ESR, Fecal calprotectin).
- The following variables were evaluated: age, sex, BMI [weight (kg)/height (m)²], Calories per day, vitamins intake, method of divert, offsprings evaluation ( weight, height, head circumference, growth velocity, lactation evaluation and vitamins intake), history of IBD-related surgeries, current and prior concomitant medications, disease duration
Description
Inclusion Criteria:
- All pregnant women and documented IBD diagnosis.
- The diagnosis of IBD was based on the patient's history supported by clinical, endoscopic and histologic documentation
Exclusion Criteria:
- Inability to provide informed consent
- HIV/Aids, multi-fetus pregnancy, fetal chromosomal or structural abnormalities
- intrauterine growth restriction, active infection (including chorioamnionitis or sepsis), renal disease, or a dietary regime that conflicts with the intervention diet.
- Pregnant IBD patients who had active perianal or extra-intestinal disease or were treated with antibiotic therapy or steroids at recruitment
- Women scheduled for C-section prior to week 37
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Dietary Patterns and Diet Quality Among Pregnant Women with Inflammatory Bowel Disease and Their Association with Pregnancy Outcomes and Infant Growth
Time Frame: Data collection: During pregnancy (across trimesters) and follow-up until infant growth assessment (e.g., up to 12-24 months after delivery)
|
This study aims to evaluate dietary patterns and overall diet quality among pregnant women diagnosed with Inflammatory Bowel Disease.
It further seeks to examine the relationship between maternal dietary patterns, adherence to pregnancy dietary guidelines, and their impact on perinatal outcomes as well as infant growth.
The findings are expected to provide insights into nutritional gaps and inform dietary recommendations for this specific population.
|
Data collection: During pregnancy (across trimesters) and follow-up until infant growth assessment (e.g., up to 12-24 months after delivery)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 04-2026-300837
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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