NCT02460575 (PRIDEC Peru) is a Phase 1 clinical trial of Lactobacillus reuteri 17938 in Healthy, sponsored by Tulane University School of Medicine.

Who is sponsoring NCT02460575?

NCT02460575 is sponsored by Tulane University School of Medicine.

What drugs are being tested in NCT02460575?

Interventions in NCT02460575: Lactobacillus reuteri 17938, Placebo.

Is NCT02460575 still recruiting?

NCT02460575 is currently completed. Last updated 4 May 2020.

Are results published for NCT02460575?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-05-04 · How we verify

NCT02460575: PRIDEC Peru

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety of Lactobacillus Reuteri in Healthy Children Aged 2-24 Months

Completed Phase 1 Results posted Last updated 4 May 2020

What this trial tests

Phase 1 trial testing Lactobacillus reuteri 17938 in Healthy in 60 participants. Completed in 29 December 2019.

Timeline

9 January 2019

Primary endpoint
29 December 2019

29 December 2019

Quick facts

Lead sponsor	Tulane University School of Medicine
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	9 January 2019
Primary completion	29 December 2019
Estimated completion	29 December 2019
Sites	1 location across Peru

Drugs / interventions tested

Lactobacillus reuteri 17938 — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Tulane University School of Medicine

Who can join

Adults 2 Months to 24 Months, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Positive Blood Culture for L. Reuteri Primary · Participants are followed for an average of 36 days

number of participants with positive blood culture for L. reuteri

Group	Value	95% CI
Lactobacillus	0
Placebo	0

Mean Daily Temperature Primary · 5 days of study product administration

Group	Value	95% CI
Lactobacillus	36.5	± 0.23
Placebo	36.5	± 0.23

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 month followup period. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lactobacillus

Serious: 0/40 (0%)

Deaths: 0/40

Placebo

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (8 terms — click to expand)

Reaction	System	Lactobacillus	Placebo
All	General disorders	—	—
Fever	General disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Wheezing	Respiratory, thoracic and mediastinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Irritability	General disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Pruritis	General disorders	—	—

Data from ClinicalTrials.gov NCT02460575 adverse events section.

Sponsor's own description

Phase I double blinded randomized trial of the safety and tolerability of Lactobacillus reuteri DSM 17938 given for five successive days in healthy children. Sixty children will receive study product at a treatment to placebo ratio of 2:1 and followed for 3 months for safety outcomes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Tulane University School of Medicine trials

Trials by the same sponsor.

NCT05170789 — Elotuzumab, Selinexor, and Dexamethasone for Relapsed Refractory Multiple Myeloma · Phase 2 · withdrawn
NCT04704050 — Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence · Phase 4 · terminated
NCT04347811 — Use of Death Cafes to Prevent Burnout in ICU Healthcare Employees · NA · completed
NCT04305353 — Intensive Care Unit (ICU) Diary Project · NA · completed
NCT03305081 — Patient Compliance With Long-Acting Reversible Contraception Administration · NA · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02460575 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tulane University School of Medicine
Last refreshed: 4 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02460575.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing