AntibioticNCT07532421
Probiotic Intervention on the Development of Allergic Diseases in Infants Exposed to Antibiotics Early in Life
A study testing Probiotic mixture in people with Antibiotic and Allergic Diseases, run by Peking University Third Hospital at 1 site in China.
Trial summary
Early antibiotic exposure is an important environmental factor that disrupts the establishment of the infant gut microbiota and leads to microbial dysbiosis. Accumulating epidemiological evidence indicates that exposure to antibiotics early in life (including both prenatal and postnatal periods) is significantly… Read more about this study
- Who is it for?
- Ages 1 day to 35 daysHealthy volunteers can take part
- Conditions the study is for
- Antibiotic, Allergic Diseases, Infants
- What is being tested?
- Probiotic mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2026to 31 Oct 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 1 day to 35 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age from 37 weeks to less than 41 weeks;
- Birth weight between the 10th and 90th percentiles for gestational age;
- Breastfed (exclusively breastfed after achieving stable feeding volume, with willingness to maintain exclusive breastfeeding for at least 3 months);
- Postnatal age within 35 days; Consent to participate in this study.
Who cannot join
- Postnatal Apgar score <7;
- Presence of severe congenital malformations or inherited metabolic diseases;
- Use of probiotics by the infant or the mother within 2 weeks before enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: A Study on the Impact of Probiotic Intervention on the Development of Allergic Diseases in Infants Exposed to Antibiotics Early in Life
Early antibiotic exposure is an important environmental factor that disrupts the establishment of the infant gut microbiota and leads to microbial dysbiosis. Accumulating epidemiological evidence indicates that exposure to antibiotics early in life (including both prenatal and postnatal periods) is significantly associated with an increased risk of allergic diseases in childhood. As live microorganisms, probiotics hold potential as a preventive strategy against allergies due to their ability to stabilize the intestinal barrier and regulate immune balance (e.g., promoting Th1/Th2 balance, inducing regulatory T cells, and increasing sIgA secretion). However, current studies have mostly focused on general or high-risk infant populations. For the specific high-risk subgroup that has already been exposed to antibiotics early in life, high-quality randomized controlled trial evidence is still lacking regarding whether probiotic intervention can effectively reduce the incidence of allergies and whether it exerts its effects by reshaping the gut microbiota and metabolites disrupted by antibiotics.
This study focuses on breastfed infants who received antibiotics during the early postnatal period (within 30 days after birth) and aims to investigate the effect of a probiotic mixture containing Bifidobacterium longum subsp. infantis R0033, Lactobacillus helveticus R0052, and Bifidobacterium bifidum R0071 on the development of allergic diseases after antibiotic exposure.
Read the detailed description
Allergic diseases are a major global public health problem, affecting approximately 30%-40% of the population. Food allergy (FA) often represents the starting point of the atopic march in children and can subsequently progress to atopic dermatitis, asthma, allergic rhinitis, and other conditions, severely impacting quality of life. Early life is a critical "window period" for the development and maturation of the immune system, in which the gut microbiota plays a central role. The interaction between the gut microbiota and the host immune system is essential for the establishment of immune tolerance.
Early antibiotic exposure is an important environmental factor that disrupts the establishment of the infant gut microbiota and leads to microbial dysbiosis. Accumulating epidemiological evidence indicates that exposure to antibiotics early in life (including both prenatal and postnatal periods) is significantly associated with an increased risk of allergic diseases in childhood. The underlying mechanism may involve antibiotic-induced disruption of the gut microbiota, which in turn affects immune balance and skews the immune response toward a Th2-dominant (allergy-prone) phenotype. However, the specific host-microbiota interactions involved have not yet been fully elucidated.
As live microorganisms, probiotics hold potential as a preventive strategy against allergies due to their ability to stabilize the intestinal barrier and regulate immune balance (e.g., promoting Th1/Th2 balance, inducing regulatory T cells, and increasing secretory IgA secretion). However, current studies have mostly focused on general or high-risk infant populations. For the specific high-risk subgroup that has already been exposed to antibiotics early in life, high-quality randomized controlled trial evidence is still lacking regarding whether probiotic intervention can effectively reduce the incidence of allergies and whether it exerts its effects by reshaping the gut microbiota and metabolites disrupted by antibiotics.
This study focuses on breastfed infants who received antibiotics during the early postnatal period (within 30 days after birth) and aims to investigate the effect of a probiotic mixture on the development of allergic diseases after antibiotic exposure.
The study plans to enroll infants with early-life antibiotic exposure as the study population. Starting at 1 month of age, they will be randomly assigned to a probiotic intervention group or a placebo group, while infants who have never received antibiotics will be included as a control group.
Infants in the intervention group will receive an oral probiotic formulation for 8 weeks, whereas those in the placebo group will receive a placebo without probiotics. During the one-year follow-up period, the occurrence of food allergic diseases in each group will be documented in detail, including the time of onset, type, and severity of symptoms. In addition, growth and development indicators, gut microbiota composition, and metabolomic profiles will be regularly monitored to further explore the potential mechanisms of action of the probiotic intervention.
- Conditions
- Antibiotic, Allergic Diseases, Infants, Probiotic
- Being tested
- Probiotic mixture, Placebo
- Keywords
- probiotics, infants, early postnatal antibiotic exposure, allergic diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic mixtureDietary supplement
Oral probiotic mixture for 8 weeks, once daily, one sachet per day
PlaceboOther
Oral a placebo without probiotics for 8 weeks, once daily, one sachet per day.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group consists of full-term healthy newborns who have not received antibiotics within 30 days after birth. No intervention will be given; they will only be followed up for the occurrence of allergic diseases and infectious diseases within the first year of life. During the follow-up period, four stool samples will be collected for the analysis of gut microbiota and their metabolites. |
| Probiotic intervention group | Experimental | The probiotic intervention group will recruit full-term newborns who have received antibiotics within 30 days after birth. Starting at 5 weeks of age, they will receive an 8-week course of an oral probiotic mixture (containing Bifidobacterium longum subsp. infantis R0033, Lactobacillus helveticus R0052, and Bifidobacterium bifidum R0071). They will be followed up for the occurrence of allergic diseases and infectious diseases within the first year of life. During the follow-up period, four stool samples will be collected for the analysis of gut microbiota and their metabolites. Receives: Dietary Supplement: Probiotic mixture |
| Placebo group | Placebo comparator | The placebo group will recruit full-term newborns who have received antibiotics within 30 days after birth. Starting at 5 weeks of age, they will receive an 8-week course of an oral placebo without the probiotic. They will be followed up for the occurrence of allergic diseases and infectious diseases within the first year of life. During the follow-up period, four stool samples will be collected for the analysis of gut microbiota and their metabolites. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of allergic diseases in infants
Compare the incidence of allergic diseases between the antibiotic-exposed group and the control group, and analyze the effects of antibiotic exposure intensity, frequency, and type on the development of allergic diseases. Furthermore, compare the incidence of allergic diseases among the probiotic intervention group, the placebo group, and the control group.
Measured: Follow up until the enrolled infants reach 1 year of age.
Changes in gut microbiota composition in the antibiotic-exposed group
Compare the changes in gut microbiota composition of infants in the antibiotic-exposed group at enrollment (1 month of age) and at 3, 6, and 12 months of age, compare the differences in gut microbiota composition among the three groups, and analyze the effect of antibiotic exposure intensity on gut microbiota composition.
Measured: At enrollment (1 month of age) and at 3, 6, and 12 months of age
Changes in fecal metabolites in infants of the probiotic intervention group
Compare the changes in fecal metabolites between the probiotic intervention group and the placebo group, and explore the potential mechanisms by which specific probiotic intervention induces alterations in gut metabolites.
Measured: At 3, 6, and 12 months of age
Secondary outcomes (2)
Growth curves of infants in the antibiotic-exposed group and the control group
Compare the growth curves and developmental parameters between the antibiotic-exposed group and the control group.
Measured: At 3, 6, 9, and 12 months of age.
Proportion of infectious diseases in infants of the antibiotic-exposed group and the control group
Compare the frequency, types, and proportion of infectious diseases between the antibiotic-exposed group and the control group.
Measured: Follow up until the infant reaches 1 year of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start17 Apr 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for AntibioticStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532421
- Sponsor's protocol ID
- IRB00006761-M20251233
- Other IDs
- CON202602149245
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baron R, Taye M, der Vaart IB, Ujcic-Voortman J, Szajewska H, Seidell JC, Verhoeff A. The relationship of prenatal antibiotic exposure and infant antibiotic administration with childhood allergies: a systematic review. BMC Pediatr. 2020 Jun 27;20(1):312. doi: 10.1186/s12887-020-02042-8.
PubMed 32593308Brough HA, Lanser BJ, Sindher SB, Teng JMC, Leung DYM, Venter C, Chan SM, Santos AF, Bahnson HT, Guttman-Yassky E, Gupta RS, Lack G, Ciaccio CE, Sampath V, Nadeau KC, Nagler CR. Early intervention and prevention of allergic diseases. Allergy. 2022 Feb;77(2):416-441. doi: 10.1111/all.15006. Epub 2021 Sep 7.
PubMed 34255344Ding M, Li B, Chen H, Ross RP, Stanton C, Jiang S, Zhao J, Chen W, Yang B. Bifidobacterium longum subsp. infantis regulates Th1/Th2 balance through the JAK-STAT pathway in growing mice. Microbiome Res Rep. 2024 Jan 19;3(2):16. doi: 10.20517/mrr.2023.64. eCollection 2024.
PubMed 38841405Shamji MH, Fulton WT, Animashaun I, Palmer E, Baerenfaller K, Sokolowska M, Barber D, Huffaker M, Baloh C, Pfaar O, Ollert M, Klimek L, Rabin RL, Tripathi A, Togias A, Vieths S, Shreffler WG, Layhadi JA. Multiomics approach to evaluating personalized biomarkers of allergen immunotherapy. J Allergy Clin Immunol. 2025 Sep;156(3):523-534. doi: 10.1016/j.jaci.2025.06.036.
PubMed 40914606Li M, Lu ZK, Amrol DJ, Mann JR, Hardin JW, Yuan J, Cox CL, Love BL. Antibiotic Exposure and the Risk of Food Allergy: Evidence in the US Medicaid Pediatric Population. J Allergy Clin Immunol Pract. 2019 Feb;7(2):492-499. doi: 10.1016/j.jaip.2018.09.036. Epub 2018 Nov 20.
PubMed 30468878Grimshaw KEC, Roberts G, Selby A, Reich A, Butiene I, Clausen M, Dubakiene R, Fiandor A, Fiocchi A, Grabenhenrich LB, Larco JI, Kowalski ML, Rudzeviciene O, Papadopoulos NG, Rosenfeld L, Sigurdardottir ST, Sprikkelman AB, Schoemaker AA, Xepapadaki P, Mills ENC, Keil T, Beyer K. Risk Factors for Hen's Egg Allergy in Europe: EuroPrevall Birth Cohort. J Allergy Clin Immunol Pract. 2020 Apr;8(4):1341-1348.e5. doi: 10.1016/j.jaip.2019.11.040. Epub 2019 Dec 14.
PubMed 31846795Metzler S, Frei R, Schmausser-Hechfellner E, von Mutius E, Pekkanen J, Karvonen AM, Kirjavainen PV, Dalphin JC, Divaret-Chauveau A, Riedler J, Lauener R, Roduit C; PASTURE/EFRAIM study group. Association between antibiotic treatment during pregnancy and infancy and the development of allergic diseases. Pediatr Allergy Immunol. 2019 Jun;30(4):423-433. doi: 10.1111/pai.13039. Epub 2019 Mar 5.
PubMed 30734960Zhong Y, Zhang Y, Wang Y, Huang R. Maternal antibiotic exposure during pregnancy and the risk of allergic diseases in childhood: A meta-analysis. Pediatr Allergy Immunol. 2021 Apr;32(3):445-456. doi: 10.1111/pai.13411. Epub 2020 Dec 2.
PubMed 33190323Ren HL, Sun JL, Liu G. [Comorbidity and multimorbidity for allergic diseases]. Zhonghua Yu Fang Yi Xue Za Zhi. 2022 Jun 6;56(6):735-739. doi: 10.3760/cma.j.cn112150-20220312-00229. Chinese.
PubMed 35785854
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Impact of Probiotic Intervention on the Development of Allergic Diseases in Infants Exposed to Antibiotics Early in Life
- ClinicalTrials.gov ID
- NCT07532421
- Acronym / sponsor ID
- IRB00006761-M20251233
- Conditions
- Antibiotic, Allergic Diseases, Infants, Probiotic
- Keywords
- probiotics, infants, early postnatal antibiotic exposure, allergic diseases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 17 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 15 Apr 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.
Early antibiotic exposure is an important environmental factor that disrupts the establishment of the infant gut microbiota and leads to microbial dysbiosis. Accumulating epidemiological evidence indicates that exposure to antibiotics early in life (including both prenatal and postnatal periods) is significantly associated with an increased risk of allergic diseases in childhood. As live microorganisms, probiotics hold potential as a preventive strategy against allergies due to their ability to stabilize the intestinal barrier and regulate immune balance (e.g., promoting Th1/Th2 balance, inducing regulatory T cells, and increasing sIgA secretion). However, current studies have mostly focused on general or high-risk infant populations. For the specific high-risk subgroup that has already been exposed to antibiotics early in life, high-quality randomized controlled trial evidence is still lacking regarding whether probiotic intervention can effectively reduce the incidence of allergies and whether it exerts its effects by reshaping the gut microbiota and metabolites disrupted by antibiotics.
This study focuses on breastfed infants who received antibiotics during the early postnatal period (within 30 days after birth) and aims to investigate the effect of a probiotic mixture containing Bifidobacterium longum subsp. infantis R0033, Lactobacillus helveticus R0052, and Bifidobacterium bifidum R0071 on the development of allergic diseases after antibiotic exposure.
Detailed description
Allergic diseases are a major global public health problem, affecting approximately 30%-40% of the population. Food allergy (FA) often represents the starting point of the atopic march in children and can subsequently progress to atopic dermatitis, asthma, allergic rhinitis, and other conditions, severely impacting quality of life. Early life is a critical "window period" for the development and maturation of the immune system, in which the gut microbiota plays a central role. The interaction between the gut microbiota and the host immune system is essential for the establishment of immune tolerance.
Early antibiotic exposure is an important environmental factor that disrupts the establishment of the infant gut microbiota and leads to microbial dysbiosis. Accumulating epidemiological evidence indicates that exposure to antibiotics early in life (including both prenatal and postnatal periods) is significantly associated with an increased risk of allergic diseases in childhood. The underlying mechanism may involve antibiotic-induced disruption of the gut microbiota, which in turn affects immune balance and skews the immune response toward a Th2-dominant (allergy-prone) phenotype. However, the specific host-microbiota interactions involved have not yet been fully elucidated.
As live microorganisms, probiotics hold potential as a preventive strategy against allergies due to their ability to stabilize the intestinal barrier and regulate immune balance (e.g., promoting Th1/Th2 balance, inducing regulatory T cells, and increasing secretory IgA secretion). However, current studies have mostly focused on general or high-risk infant populations. For the specific high-risk subgroup that has already been exposed to antibiotics early in life, high-quality randomized controlled trial evidence is still lacking regarding whether probiotic intervention can effectively reduce the incidence of allergies and whether it exerts its effects by reshaping the gut microbiota and metabolites disrupted by antibiotics.
This study focuses on breastfed infants who received antibiotics during the early postnatal period (within 30 days after birth) and aims to investigate the effect of a probiotic mixture on the development of allergic diseases after antibiotic exposure.
The study plans to enroll infants with early-life antibiotic exposure as the study population. Starting at 1 month of age, they will be randomly assigned to a probiotic intervention group or a placebo group, while infants who have never received antibiotics will be included as a control group.
Infants in the intervention group will receive an oral probiotic formulation for 8 weeks, whereas those in the placebo group will receive a placebo without probiotics. During the one-year follow-up period, the occurrence of food allergic diseases in each group will be documented in detail, including the time of onset, type, and severity of symptoms. In addition, growth and development indicators, gut microbiota composition, and metabolomic profiles will be regularly monitored to further explore the potential mechanisms of action of the probiotic intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group consists of full-term healthy newborns who have not received antibiotics within 30 days after birth. No intervention will be given; they will only be followed up for the occurrence of allergic diseases and infectious diseases within the first year of life. During the follow-up period, four stool samples will be collected for the analysis of gut microbiota and their metabolites. |
| Probiotic intervention group | Experimental | Dietary Supplement: Probiotic mixtureThe probiotic intervention group will recruit full-term newborns who have received antibiotics within 30 days after birth. Starting at 5 weeks of age, they will receive an 8-week course of an oral probiotic mixture (containing Bifidobacterium longum subsp. infantis R0033, Lactobacillus helveticus R0052, and Bifidobacterium bifidum R0071). They will be followed up for the occurrence of allergic diseases and infectious diseases within the first year of life. During the follow-up period, four stool samples will be collected for the analysis of gut microbiota and their metabolites. |
| Placebo group | Placebo comparator | Other: PlaceboThe placebo group will recruit full-term newborns who have received antibiotics within 30 days after birth. Starting at 5 weeks of age, they will receive an 8-week course of an oral placebo without the probiotic. They will be followed up for the occurrence of allergic diseases and infectious diseases within the first year of life. During the follow-up period, four stool samples will be collected for the analysis of gut microbiota and their metabolites. |
Who may qualify
- Ages
- 1 day to 35 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age from 37 weeks to less than 41 weeks;
- Birth weight between the 10th and 90th percentiles for gestational age;
- Breastfed (exclusively breastfed after achieving stable feeding volume, with willingness to maintain exclusive breastfeeding for at least 3 months);
- Postnatal age within 35 days; Consent to participate in this study.
Key exclusion criteria (3 listed)
- Postnatal Apgar score <7;
- Presence of severe congenital malformations or inherited metabolic diseases;
- Use of probiotics by the infant or the mother within 2 weeks before enrollment.
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 |
|---|---|---|
| Probiotic mixtureOral probiotic mixture for 8 weeks, once daily, one sachet per day | Dietary supplement | Probiotic intervention group |
| PlaceboOral a placebo without probiotics for 8 weeks, once daily, one sachet per day. | Other | Placebo group |
Primary outcome
Incidence of allergic diseases in infants
Time frame: Follow up until the enrolled infants reach 1 year of age.
Compare the incidence of allergic diseases between the antibiotic-exposed group and the control group, and analyze the effects of antibiotic exposure intensity, frequency, and type on the development of allergic diseases. Furthermore, compare the incidence of allergic diseases among the probiotic intervention group, the placebo group, and the control group.
Changes in gut microbiota composition in the antibiotic-exposed group
Time frame: At enrollment (1 month of age) and at 3, 6, and 12 months of age
Compare the changes in gut microbiota composition of infants in the antibiotic-exposed group at enrollment (1 month of age) and at 3, 6, and 12 months of age, compare the differences in gut microbiota composition among the three groups, and analyze the effect of antibiotic exposure intensity on gut microbiota composition.
Changes in fecal metabolites in infants of the probiotic intervention group
Time frame: At 3, 6, and 12 months of age
Compare the changes in fecal metabolites between the probiotic intervention group and the placebo group, and explore the potential mechanisms by which specific probiotic intervention induces alterations in gut metabolites.
2 secondary outcomes
Growth curves of infants in the antibiotic-exposed group and the control group
Time frame: At 3, 6, 9, and 12 months of age.
Proportion of infectious diseases in infants of the antibiotic-exposed group and the control group
Time frame: Follow up until the infant reaches 1 year of age.
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 11 May 2026.
- Background: PubMed 32593308Baron R, Taye M, der Vaart IB, Ujcic-Voortman J, Szajewska H, Seidell JC, Verhoeff A. The relationship of prenatal antibiotic exposure and infant antibiotic administration with childhood allergies: a systematic review. BMC Pediatr. 2020 Jun 27;20(1):312. doi: 10.1186/s12887-020-02042-8.
- Background: PubMed 34255344Brough HA, Lanser BJ, Sindher SB, Teng JMC, Leung DYM, Venter C, Chan SM, Santos AF, Bahnson HT, Guttman-Yassky E, Gupta RS, Lack G, Ciaccio CE, Sampath V, Nadeau KC, Nagler CR. Early intervention and prevention of allergic diseases. Allergy. 2022 Feb;77(2):416-441. doi: 10.1111/all.15006. Epub 2021 Sep 7.
- Background: PubMed 38841405Ding M, Li B, Chen H, Ross RP, Stanton C, Jiang S, Zhao J, Chen W, Yang B. Bifidobacterium longum subsp. infantis regulates Th1/Th2 balance through the JAK-STAT pathway in growing mice. Microbiome Res Rep. 2024 Jan 19;3(2):16. doi: 10.20517/mrr.2023.64. eCollection 2024.
- Background: PubMed 40914606Shamji MH, Fulton WT, Animashaun I, Palmer E, Baerenfaller K, Sokolowska M, Barber D, Huffaker M, Baloh C, Pfaar O, Ollert M, Klimek L, Rabin RL, Tripathi A, Togias A, Vieths S, Shreffler WG, Layhadi JA. Multiomics approach to evaluating personalized biomarkers of allergen immunotherapy. J Allergy Clin Immunol. 2025 Sep;156(3):523-534. doi: 10.1016/j.jaci.2025.06.036.
- Background: PubMed 30468878Li M, Lu ZK, Amrol DJ, Mann JR, Hardin JW, Yuan J, Cox CL, Love BL. Antibiotic Exposure and the Risk of Food Allergy: Evidence in the US Medicaid Pediatric Population. J Allergy Clin Immunol Pract. 2019 Feb;7(2):492-499. doi: 10.1016/j.jaip.2018.09.036. Epub 2018 Nov 20.
- Background: PubMed 31846795Grimshaw KEC, Roberts G, Selby A, Reich A, Butiene I, Clausen M, Dubakiene R, Fiandor A, Fiocchi A, Grabenhenrich LB, Larco JI, Kowalski ML, Rudzeviciene O, Papadopoulos NG, Rosenfeld L, Sigurdardottir ST, Sprikkelman AB, Schoemaker AA, Xepapadaki P, Mills ENC, Keil T, Beyer K. Risk Factors for Hen's Egg Allergy in Europe: EuroPrevall Birth Cohort. J Allergy Clin Immunol Pract. 2020 Apr;8(4):1341-1348.e5. doi: 10.1016/j.jaip.2019.11.040. Epub 2019 Dec 14.
- Background: PubMed 30734960Metzler S, Frei R, Schmausser-Hechfellner E, von Mutius E, Pekkanen J, Karvonen AM, Kirjavainen PV, Dalphin JC, Divaret-Chauveau A, Riedler J, Lauener R, Roduit C; PASTURE/EFRAIM study group. Association between antibiotic treatment during pregnancy and infancy and the development of allergic diseases. Pediatr Allergy Immunol. 2019 Jun;30(4):423-433. doi: 10.1111/pai.13039. Epub 2019 Mar 5.
- Background: PubMed 33190323Zhong Y, Zhang Y, Wang Y, Huang R. Maternal antibiotic exposure during pregnancy and the risk of allergic diseases in childhood: A meta-analysis. Pediatr Allergy Immunol. 2021 Apr;32(3):445-456. doi: 10.1111/pai.13411. Epub 2020 Dec 2.
- Background: PubMed 35785854Ren HL, Sun JL, Liu G. [Comorbidity and multimorbidity for allergic diseases]. Zhonghua Yu Fang Yi Xue Za Zhi. 2022 Jun 6;56(6):735-739. doi: 10.3760/cma.j.cn112150-20220312-00229. Chinese.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic mixture in people with Antibiotic and Allergic Diseases, run by Peking University Third Hospital at 1 site in China.
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 3 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 11 May 2026. 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 China. 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. Some participants in this study may receive a placebo. 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 Juan Zhang, Medical Doctor (+8615611968716, arbooo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of allergic diseases in infants (time frame: Follow up until the enrolled infants reach 1 year of age.). The study lists 3 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 NCT07532421, which also lists 9 linked publications.
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 11 May 2026.