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NCT07752342

Exploring Wellbeing Outcomes in Adolescents Using Bifidobacterium Longum, 1714™

StatusActive, Not Recruiting
PhaseNot applicable
SponsorNovonesis
Primary completion (estimated)
Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Start date changed from estimate of Sep 2026 to Sep 8, 2026
    • Site contact updated
  2. Eligibility criteria expanded, about 32 words
    • Secondary endpoints revised (13)
    • Publications: details revised at 5 of 5 entries
    • Study title shortened, about 5 words
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change From Baseline to Week 4 in PROMIS Pediatric Anxiety CAT T-Score
Timeframe: Baseline to week 4.

Secondary (13)

Change From Baseline in PROMIS Pediatric Anxiety CAT T-Score at Weeks 6 and 8
Change From Baseline in PROMIS Parent Proxy Anxiety CAT T-Score
Change From Baseline in PROMIS Pediatric Cognitive Function CAT T-Score
Change From Baseline in PROMIS Parent Proxy Cognitive Function CAT T-Score
Change From Baseline in PROMIS Pediatric Depressive Symptoms CAT T-Score
Show 8 moreShow less
Change From Baseline in PROMIS Parent Proxy Depressive Symptoms CAT T-Score
Change From Baseline in PROMIS Pediatric Fatigue CAT T-Score
Change From Baseline in PROMIS Parent Proxy Fatigue CAT T-Score
Change From Baseline in PROMIS Pediatric Peer Relationships CAT T-Score
Change From Baseline in PROMIS Parent Proxy Peer Relationships CAT T-Score
Change From Baseline in PROMIS Pediatric Sleep Disturbance CAT T-Score
Change From Baseline in PROMIS Parent Proxy Sleep Disturbance CAT T-Score
PROMIS Pediatric Anxiety Responder Rate at Weeks 4, 6 and 8

Arms and interventions

Bifidobacterium longum, 1714™Experimental

One capsule containing Bifidobacterium longum, 1714™ (1 × 10⁹ CFU per capsule). The dietary supplement also contains thiamine (vitamin B1), riboflavin (vitamin B2), niacin (vitamin B3), vitamin B6, folic acid, vitamin B12, biotin and pantothenic acid, each provided at approximately 100% of the daily Nutrient Reference Value. Additional ingredients include corn starch, hydroxypropyl methylcellulose (capsule shell) and magnesium stearate.

Dietary supplements: Bifidobacterium longum, 1714™

Sites

1 site in 1 country

  • Comet ClinicalCardiff, United Kingdom