Trial Radar KI | ||
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Die klinische Studie NCT07490587 für Gesunde Kinder ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants Phase 2 366 Randomisiert Doppelblind Placebo-kontrolliert
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Die klinische Studie NCT07490587 untersucht Prävention im Zusammenhang mit Gesunde Kinder. Diese interventionsstudie der Phase 2 hat den Status offene rekrutierung und startete am 1. Januar 2024. Es ist geplant, 366 Teilnehmer aufzunehmen. Durchgeführt von Min-Tze LIONG wird der Abschluss für 30. Juni 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. März 2026 aktualisiert.
Kurzbeschreibung
This study is a 180-day randomized, double-blind, placebo-controlled trial involving healthy infants and young children under 3 years of age with elevated allergy risk. Participants are randomized to receive either Bifidobacterium animalis subsp. lactis XLTG11 probiotic or placebo daily. The primary clinical outcomes assessed are incidence and day-level burden of allergic, respiratory, and gastrointestinal symptoms. ...Mehr anzeigen
Ausführliche Beschreibung
Early childhood represents a critical developmental window during which the gut microbiome, immune system, and mucosal defense pathways undergo coordinated maturation. Dysregulation during this period contributes substantially to allergic sensitization, respiratory morbidity, and gastrointestinal disorders, which collectively represent major pediatric health burdens worldwide. Infants and young children frequently ex...Mehr anzeigen
Offizieller Titel
To Investigate the Effects of Bifidobacterium Animalis Subsp. Lactis XLTG11 on Growth and Development, Incidence of Allergy and Immune Function in Infants
Erkrankungen
Gesunde KinderWeitere Studien-IDs
- 2023-142
NCT-Nummer
Studienbeginn (tatsächlich)
2024-01-01
Zuletzt aktualisiert
2026-03-24
Studienende (vorauss.)
2026-06-30
Geplante Rekrutierung
366
Studientyp
Interventionsstudie
PHASE
Phase 2
Status
Offene Rekrutierung
Stichwörter
children
probiotic
allergy
bifidobacterium
probiotic
allergy
bifidobacterium
Primäres Ziel
Prävention
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellProbiotic One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient | Probiotikum One sachet daily containing Bifidobacterium animalis subsp. lactis XLTG11 (1 × 1010 CFU per 2 g dose) with maltodextrin as excipient |
Placebo-VergleichspräparatPlacebo One sachet daily (2 g) containing only maltodextrin as excipient | PLACEBO One sachet daily (2g) containing only maltodextrin as excipient |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Allergy symptoms in children upon administration of probiotic or placebo as assessed via clinical questionnaire | Differences in severity of allergy symptoms in children upon administration of probiotic or placebo, assessed using a hospital-based clinical questionnaire scored based on total number and duration of occurrences. | Day-0, Day-180 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Microbiota profiles of fecal samples in young children upon administration of probiotic or placebo as assessed via 16s rRNA and metagenomics gene sequencing | Differences in microbiota profiles in fecal sample of children upon administration of probiotic or placebo | Day-0, day-180 |
Gut immune biomarkers of fecal samples in young children upon administration of probiotic or placebo as assessed via Enzyme-Linked Immunosorbent Assay (ELISA) | Differences in gut immune biomarkers in fecal sample of children upon administration of probiotic or placebo, such as Human β-defensin 2 (DEFB2), cathelicidin LL-37, calprotectin, secretory immunoglobulin A (sIgA). | Day-0, Day-180 |
Defecation frequency in children upon administration of probiotic or placebo as assessed via daily stool diary | Differences in defecation frequency (stools per day) in children upon administration of probiotic or placebo, assessed using a structured daily stool diary completed by parents/guardians. | Day-0, day-180 |
Stool consistency (Bristol Stool Scale characteristics) in children upon administration of probiotic or placebo as assessed via standardized stool form classification | Differences in stool consistency in children upon administration of probiotic or placebo, assessed using the Bristol Stool Form Scale (type 1-7), with parents/guardians recording daily stool characteristics, where abnormal stools are characterized by types 1-2 (constipation) and types 6-7 (diarrhea). | Day-0, Day-180 |
Growth index (age- and sex-standardized Z-score) in children upon administration of probiotic or placebo as assessed via anthropometric measurements. | Differences in growth Z-scores in children upon administration of probiotic or placebo, assessed using calibrated anthropometric equipment, with values converted to age- and sex-standardized Z-scores according to WHO Child Growth Standards (2006). | Day-0, Day-180 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind
Mindestalter
0 Months
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
- Term infants are 37≤ gestational age < 42 weeks, and the birth weight is between 2500g and 4000g (only applicable to 0~12 months old)
- Breastfed or mixed-fed healthy infants and young children, aged 0~3 (inclusive) years old, gender is not limited
- The allergy risk score calculated by the Infant Allergy Risk Assessment Table is ≥6(Refer to the National Center for Women and Children's Health, Chinese Center for Disease Control and Prevention: Investigation and Research on Allergy Symptoms and Risk Factors in Infants and Young Children)
- Family primary guardians agree to collect fecal samples of infants and young children during this study
- Have not used antibiotics in the past month
- Have not used probiotics in the past three months
- Family primary guardians committed not to add additional Bifidobacterium dietary supplements to infants and young children during the intervention period
- The guardians of the enrolled subjects agree to participate in this interventional study and sign a written informed consent form, and are able to understand and fill in forms such as infant diaries as required
- Signed informed consent and willing to follow up at the time specified in the trial
- The mother of the infant has a history of diabetes, hepatitis B, HIV and other infectious diseases
- Clinicians diagnosed with allergic diseases (including but not limited to eczema, asthma, allergic proctocolitis, allergic rhinitis, hay fever, etc.) at the time of enrollment of infants and young children
- Infants and young children who are known to be allergic to the ingredients of probiotic products
- In the opinion of the investigator, the subject has other reasons that make it unsuitable to participate in this clinical study
Min-Tze LIONGShanghai 6th People's HospitalVerantwortliche Partei
Min-Tze LIONG, Prüfsponsor, Prof., Universiti Sains Malaysia
Zentrale Studienkontakte
Kontakt: Min Tze Liong, Ph.D., 6046532114, [email protected]
Kontakt: Jie Yuan, M.Sc., [email protected]
2 Studienstandorte in 2 Ländern
Shanghai Municipality
Shanghai Sixth People's Hospital, Pudong, Shanghai Municipality, 201306, China
Jinping Zhang, MD, Kontakt, 86 21-64369181, [email protected]
Jie Yuan, MD, Kontakt, 822137027899, [email protected]
Offene Rekrutierung
Pulau Pinang
Universiti Sains Malaysia, Pulau Pinang, Pulau Pinang, 11800, Malaysia
Min Tze Liong, Ph.D., Kontakt, 6046532114, [email protected]
Jie Yuan, MD, Kontakt, 822137027899, [email protected]
Noch nicht rekrutierend