Nutritional Effect on IBD Pregnant PatientsIBD/pregnancyNCT07560176
Impact of Nutritional Managment on Pregnancy With IBD Patients and Their Springs
An observational study of Nutritional Effect on IBD Pregnant Patients, run by Assiut University.
Trial summary
While diet can support IBD management, with the potential to positively benefit perinatal as well as longer-term health outcomes, little is known about the quality of dietary patterns among pregnant women with IBD , therefore, the objectives of our study are to assess the dietary patterns and diet quality of pregnant… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Nutritional Effect on IBD Pregnant Patients
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Apr 2028
- Phase
- Observational
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
While diet can support IBD management, with the potential to positively benefit perinatal as well as longer-term health outcomes, little is known about the quality of dietary patterns among pregnant women with IBD , therefore, the objectives of our study are to assess the dietary patterns and diet quality of pregnant women with IBD, and to examine the associations between dietary patterns, diet quality, and dietary guidelines for pregnancy and growth of their offerings
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Patterns and Diet Quality Among Pregnant Women with Inflammatory Bowel Disease and Their Association with Pregnancy Outcomes and Infant Growth
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.
Measured: Data collection: During pregnancy (across trimesters) and follow-up until infant growth assessment (e.g., up to 12-24 months after delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional Effect on IBD Pregnant PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560176
- Sponsor's protocol ID
- 04-2026-300837
- Acronym
- IBD/pregnancy
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nutritional Managment on Pregnancy With IBD Patients and Their Springs
- ClinicalTrials.gov ID
- NCT07560176
- Acronym / sponsor ID
- IBD/pregnancy / 04-2026-300837
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
While diet can support IBD management, with the potential to positively benefit perinatal as well as longer-term health outcomes, little is known about the quality of dietary patterns among pregnant women with IBD , therefore, the objectives of our study are to assess the dietary patterns and diet quality of pregnant women with IBD, and to examine the associations between dietary patterns, diet quality, and dietary guidelines for pregnancy and growth of their offerings
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional Effect on IBD Pregnant Patients, run by Assiut University.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Amira Mohamed Abdelmawgod, MD (01012760437, amiramohmad60@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.