PregnancyNCT04885959
Traditional Asian Diet and Gut Microbiome and Metabolome in Healthy Volunteers and Pregnancy on Infant's Allergy Development
A study testing Traditional Asian Diet in people with Pregnancy and Food Hypersensitivity, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial summary
The research aims to elucidate a specially-designed personalized diet based on Traditional Asian Diet and its efficacy in increasing the gut colonization of Prevotella sp. and butyrate levels in pregnant mothers and the benefits in reducing infant's food allergy development. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Food Hypersensitivity, Healthy
- What is being tested?
- Traditional Asian Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2021to 30 Dec 2025
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Malaysian and of the Malay ethnicity
- Living in Kelantan for at least 5 years
- Age 18 to 40 years
- The lower limit of ≥16th weeks and the upper limit of <20th week of gestation during enrollment to allow at least 20 weeks of dietary intervention prior to delivery. The gestational age was based on the last menstrual period (LMP) or early ultrasound examination
- Singleton pregnancy
- History of personal and family history of allergy (presence of reported or doctor-diagnosed allergic disease including asthma, eczema, food allergy, or allergy rhinitis) in participants, their partners or in their previous child or pregnancy.
Show all 9Show fewer
- In attendance of antenatal clinic at Hospital USM or Klinik Kesihatan (Kota Bharu/Kubang Kerian/Pengkalan Chepa)
- Living area within 10 km radius of Kota Bharu, Kelantan
- Consent to participate
Who cannot join
- Significant present or having past medical history of chronic disease for example bowel, cancer disease, systemic lupus erythematosus (SLE), chronic kidney disease, heart failure, stroke, haematological malignancy, and chronic obstructive pulmonary disease.
- Significant psychiatric history including major depression and other psychotic disorders.
- Significant present or past surgical history including bowel surgeries
- Significant presence of doctor-diagnosed short intestinal bacteria overgrowth (SIBO).
- Taking any medications which may disturb the gut microbiota or intestinal function, for example, antibiotics for the past 3 months, immunosuppressive drugs, opiates, anticoagulants and etc.
- Those who plan to move out from Kelantan after delivery which may affect the follow-up.
- Those who follow a vegetarian diet will also be excluded from participating.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan, 16150
About this study
Official title: The Effects of Traditional Asian Diet on Gut Microbiome and Metabolome in Healthy Volunteers and Pregnancy on Subsequent Infant's Allergy Development
The research aims to elucidate a specially-designed personalized diet based on Traditional Asian Diet and its efficacy in increasing the gut colonization of Prevotella sp. and butyrate levels in pregnant mothers and the benefits in reducing infant's food allergy development.
Read the detailed description
A preliminary pilot study is first will be conducted among a group of healthy volunteers. This pilot study aims to assess the feasibility of the intervention and obtain pre-eliminary data on its efficacy before proceeding to the full-scale research study. Next, in the actual trial among pregnant mothers, participants will be informed about the study and potential risk. All patients giving written informed consent will go one week screening period to assess for study eligibility prior to enrollment. At week 0, single-blind randomization (subject and health care providers except for principal investigator) will be conducted and participant will be randomized into two groups namely; the control group and the intervention group. The control group will receive standard dietary counselling on a healthy pregnancy diet. Meanwhile, the intervention group will receive dietary intervention which is tailored to the study objective to increase targeted bacteria of Prevotella sp and the short-chain fatty acids namely butyrate. The trial will be in 20 weeks duration during pregnancy and additional 12-months follow up for the delivered infants.
- Conditions
- Pregnancy, Food Hypersensitivity, Healthy
- Being tested
- Traditional Asian Diet
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Asian DietBehavioural
The personalized traditional Asian diet will be formulated based on dietary components of a typical Asian diet characterized by high intake of fruits and vegetables, whole grains, legumes, nuts, seeds, soy foods and herbs and spices; moderate intake of fish, poultry, eggs, healthy cooking oils, yogurt or functional foods and low intake of meats and sweets (Ismail et al., 2020). The diet design also considering the recommendation of personalized dietary approach by including the element of individual preferences, requirement, cultural preferences, affordability and foods availability to facilitate the adherence and response to the diet.
| Study group | Role | What they receive |
|---|---|---|
| Usual diet | No intervention | In the pilot study among healthy volunteers, participant need to maintain their habitual diet for 4 weeks. Meanwhile, in the large-scale study among pregnant women, participants are subjected to receive general dietary advice for healthy pregnancy from attended nurses or physician during their antenatal visits. |
| Traditional Asian Diet | Experimental | Participants will receive dietary intervention on a traditional Asian diet which diet consists of high fiber, moderate protein, and low fat and with the inclusion of local probiotics and prebiotics food sources which are known to enhance gut health by fostering the gut colonization of beneficial bacteria and promoting the production of SCFA.
During the pilot phase the diet is given for four weeks. Meanwhile, the intervention among pregnant mothers, the intervention is given for 20 weeks considering the nature of the availability of pregnant mothers being recruited where most of them (low risk pregnancy) were given their first clinic appointment at 16 weeks of gestational age. Receives: Behavioral: Traditional Asian Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal gut microbiome composition before and after intervention
Maternal stool samples will be collected at three pre-determined intervals (baseline (week 16), week-28 and week-36 gestation. The gut microbiota composition will be examined using the 16s rRNA sequencing. The alpha (Shannon, Simpson and Evenness Indices) and beta diversity of the gut microbiota will be compared within and between groups.
Measured: 20 weeks
Maternal stool metabolome concentration of short chain fatty acids (SCFA) before and after intervention
Maternal stool samples will be collected at three pre-determined intervals (baseline (week 16), week-28 and week-36 gestation. The changes in stool SCFA concentration in (umol/g) will analyzed using the gas chromatography - mass spectrometry (GC-MS). The concentration (umol/g) be compared within and between groups.
Measured: 20 weeks
Incidence of allergy development in the delivered infants and its correlation with maternal gut microbiome during pregnancy.
Symptoms perceived by parents/caregivers will be asked during postnatal follow-ups at day day-28, 3, 6 and 12 months of age using a validated questionnaire, the Comprehensive Early Childhood Allergy Questionnaire (CECAQ) (Minasyan A. et al.,2015). The results are then correlated with the maternal gut microbiome composition during pregnancy which was first being examined through the 16S rRNA sequencing analysis.
Measured: 12 months
Incidence of allergy development in the delivered infants and its correlation with maternal stool metabolome during pregnancy.
Symptoms perceived by parents/caregivers will be asked during postnatal follow-ups at day day-28, 3, 6 and 12 months of age using a validated questionnaire, the Comprehensive Early Childhood Allergy Questionnaire (CECAQ) (Minasyan A. et al.,2015). The results are then correlated with the maternal gut microbiome composition during pregnancy which was first being examined through the 16S rRNA sequencing analysis.
Measured: 12 months
Secondary outcomes (4)
Infant's gut microbiome composition at neonatal age and its correlation with allergy development
Infant's stool samples collected during the neonatal age (day-0 to day-28 post delivery). The stool DNA will be extracted to examine the gut microbiome composition through 16s rRNA sequencing. The alpha (Shannon, Simpson and Evenness Indices) and beta diversity of the gut microbiota will be correlate with the incidence of allergy.
Measured: 12 months
Infant's stool metabolome of the short-chain fatty acids (SCFA) concentration during neonatal age and its correlation with allergy development
Infant's stool samples collected during the neonatal age (day-0 to day-28 post delivery). The stool concentration of the SCFA measured in umol/g will be analyzed using the gas chromatography-mass spectrometry (GC-MS). The concentration of the SCFA (in umol/g) will be correlate with the incidence of allergy.
Measured: 12 months
Infant's immune functions and allergy development
Infant's immune function (measured by concentration of interleukin-10/IL-10, and transforming growth factor-beta/TGF-B). The plasma will be assayed IL-10 and transforming growth factor beta (TGF-β) using the ELISA kits following the manufacturer and the concentration measured in ng/mL. The concentrations IL-10 and TGF-Beta (ng/mL) will be further examined its correlation with allergy development in infants.
Measured: 12 months
Infant's gut barrier and allergy development
Infant's gut barrier will be measured through the serum FABP2, a marker of intestinal integrity (Vreugdenhil et al., 2011). The plasma will be assayed using the Human FABP2 ELISA kit following manufacturer instructions. The concentration of the FABP2 measured in ng/mL will be further examined its correlation with allergy development in infants.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Sep 2021
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nur-Fazimah Sahran, Universiti Sains Malaysia
- Investigators
- NUR-FAZIMAH SAHRAN, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885959
- Sponsor's protocol ID
- USM/JEPeM/20120611
- Status last verified
- Feb 2025
- First submitted
- 9 May 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Publications
Sahran NF, Chong CW, Ismail IH, Taib F, Hoo PS, Palanisamy UD, Sundralingam U, Teh CSJ, Kong ZX, Ayub Q, Yoke Ling F, Hazlan SNH, Azlan M, Abdul Razak S, Tengku Din TADA, Abdullah N, Tagiling N, Tee V, Ehab Ayad M, Zheng FM, El-Omar E, Lee YY. Effects of Traditional Asian Diet on dietary fibre requirement, gut microbiome composition, and faecal and urine metabolomes in healthy Asian women: a pilot study. Benef Microbes. 2025 Apr 22;17(1):47-60. doi: 10.1163/18762891-bja00074.
PubMed 40312033
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Traditional Asian Diet on Gut Microbiome and Metabolome in Healthy Volunteers and Pregnancy on Subsequent Infant's Allergy Development
- ClinicalTrials.gov ID
- NCT04885959
- Acronym / sponsor ID
- USM/JEPeM/20120611
- Conditions
- Pregnancy, Food Hypersensitivity, Healthy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 13 May 2021 (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.
The research aims to elucidate a specially-designed personalized diet based on Traditional Asian Diet and its efficacy in increasing the gut colonization of Prevotella sp. and butyrate levels in pregnant mothers and the benefits in reducing infant's food allergy development.
Detailed description
A preliminary pilot study is first will be conducted among a group of healthy volunteers. This pilot study aims to assess the feasibility of the intervention and obtain pre-eliminary data on its efficacy before proceeding to the full-scale research study. Next, in the actual trial among pregnant mothers, participants will be informed about the study and potential risk. All patients giving written informed consent will go one week screening period to assess for study eligibility prior to enrollment. At week 0, single-blind randomization (subject and health care providers except for principal investigator) will be conducted and participant will be randomized into two groups namely; the control group and the intervention group. The control group will receive standard dietary counselling on a healthy pregnancy diet. Meanwhile, the intervention group will receive dietary intervention which is tailored to the study objective to increase targeted bacteria of Prevotella sp and the short-chain fatty acids namely butyrate. The trial will be in 20 weeks duration during pregnancy and additional 12-months follow up for the delivered infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual diet | No intervention | –In the pilot study among healthy volunteers, participant need to maintain their habitual diet for 4 weeks. Meanwhile, in the large-scale study among pregnant women, participants are subjected to receive general dietary advice for healthy pregnancy from attended nurses or physician during their antenatal visits. |
| Traditional Asian Diet | Experimental | Behavioral: Traditional Asian DietParticipants will receive dietary intervention on a traditional Asian diet which diet consists of high fiber, moderate protein, and low fat and with the inclusion of local probiotics and prebiotics food sources which are known to enhance gut health by fostering the gut colonization of beneficial bacteria and promoting the production of SCFA. During the pilot phase the diet is given for four weeks. Meanwhile, the intervention among pregnant mothers, the intervention is given for 20 weeks considering the nature of the availability of pregnant mothers being recruited where most of them (low risk pregnancy) were given their first clinic appointment at 16 weeks of gestational age. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Malaysian and of the Malay ethnicity
- Living in Kelantan for at least 5 years
- Age 18 to 40 years
- The lower limit of ≥16th weeks and the upper limit of <20th week of gestation during enrollment to allow at least 20 weeks of dietary intervention prior to delivery. The gestational age was based on the last menstrual period (LMP) or early ultrasound examination
- Singleton pregnancy
Key exclusion criteria (7 listed)
- Significant present or having past medical history of chronic disease for example bowel, cancer disease, systemic lupus erythematosus (SLE), chronic kidney disease, heart failure, stroke, haematological malignancy, and chronic obstructive pulmonary disease.
- Significant psychiatric history including major depression and other psychotic disorders.
- Significant present or past surgical history including bowel surgeries
- Significant presence of doctor-diagnosed short intestinal bacteria overgrowth (SIBO).
- Taking any medications which may disturb the gut microbiota or intestinal function, for example, antibiotics for the past 3 months, immunosuppressive drugs, opiates, anticoagulants and etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Asian DietThe personalized traditional Asian diet will be formulated based on dietary components of a typical Asian diet characterized by high intake of fruits and vegetables, whole grains, legumes, nuts, seeds, soy foods and herbs and spices; moderate intake of fish, poultry, eggs, healthy cooking oils, yogurt or functional foods and low intake of meats and sweets (Ismail et al., 2020). The diet design also considering the recommendation of personalized dietary approach by including the element of individual preferences, requirement, cultural preferences, affordability and foods availability to facilitate the adherence and response to the diet. | Behavioural | Traditional Asian Diet |
Primary outcome
Maternal gut microbiome composition before and after intervention
Time frame: 20 weeks
Maternal stool samples will be collected at three pre-determined intervals (baseline (week 16), week-28 and week-36 gestation. The gut microbiota composition will be examined using the 16s rRNA sequencing. The alpha (Shannon, Simpson and Evenness Indices) and beta diversity of the gut microbiota will be compared within and between groups.
Maternal stool metabolome concentration of short chain fatty acids (SCFA) before and after intervention
Time frame: 20 weeks
Maternal stool samples will be collected at three pre-determined intervals (baseline (week 16), week-28 and week-36 gestation. The changes in stool SCFA concentration in (umol/g) will analyzed using the gas chromatography - mass spectrometry (GC-MS). The concentration (umol/g) be compared within and between groups.
Incidence of allergy development in the delivered infants and its correlation with maternal gut microbiome during pregnancy.
Time frame: 12 months
Symptoms perceived by parents/caregivers will be asked during postnatal follow-ups at day day-28, 3, 6 and 12 months of age using a validated questionnaire, the Comprehensive Early Childhood Allergy Questionnaire (CECAQ) (Minasyan A. et al.,2015). The results are then correlated with the maternal gut microbiome composition during pregnancy which was first being examined through the 16S rRNA sequencing analysis.
Incidence of allergy development in the delivered infants and its correlation with maternal stool metabolome during pregnancy.
Time frame: 12 months
Symptoms perceived by parents/caregivers will be asked during postnatal follow-ups at day day-28, 3, 6 and 12 months of age using a validated questionnaire, the Comprehensive Early Childhood Allergy Questionnaire (CECAQ) (Minasyan A. et al.,2015). The results are then correlated with the maternal gut microbiome composition during pregnancy which was first being examined through the 16S rRNA sequencing analysis.
4 secondary outcomes
Infant's gut microbiome composition at neonatal age and its correlation with allergy development
Time frame: 12 months
Infant's stool metabolome of the short-chain fatty acids (SCFA) concentration during neonatal age and its correlation with allergy development
Time frame: 12 months
Infant's immune functions and allergy development
Time frame: 12 months
Infant's gut barrier and allergy development
Time frame: 12 months
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 10 Feb 2025.
- Derived from this study: PubMed 40312033Sahran NF, Chong CW, Ismail IH, Taib F, Hoo PS, Palanisamy UD, Sundralingam U, Teh CSJ, Kong ZX, Ayub Q, Yoke Ling F, Hazlan SNH, Azlan M, Abdul Razak S, Tengku Din TADA, Abdullah N, Tagiling N, Tee V, Ehab Ayad M, Zheng FM, El-Omar E, Lee YY. Effects of Traditional Asian Diet on dietary fibre requirement, gut microbiome composition, and faecal and urine metabolomes in healthy Asian women: a pilot study. Benef Microbes. 2025 Apr 22;17(1):47-60. doi: 10.1163/18762891-bja00074.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
Related trials for Pregnancy
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
NUR-FAZIMAH SAHRAN principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Asian Diet in people with Pregnancy and Food Hypersensitivity, run by Universiti Sains Malaysia at 1 site in Malaysia.
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 9 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 10 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 1 site in Malaysia. 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?
Maternal gut microbiome composition before and after intervention (time frame: 20 weeks). The study lists 4 primary outcomes in all. 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 NCT04885959, which also lists 1 linked publication.
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 10 Feb 2025.