Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05129384 · ClinicalTrials.gov registry record · NA

The COLIC Study: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic

A NA study, sponsored by Evolve BioSystems.

Terminated
Registry status
NA
Development phase
1
Enrollment target

NCT05129384: Clinical Trial NA study, sponsored by Evolve BioSystems.

NCT05129384 is a NA study that was terminated before completion, run by Evolve BioSystems. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05129384, a NA study, was terminated before completion, sponsored by Evolve BioSystems.

TERMINATED
Registry status
NA
Development phase
1 participants
Enrollment target

Study Summary

To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic

Primary Outcome

Assess the effect of the probiotic, B. infantis EVC001, on duration of crying/fussing symptoms of breastfed infants diagnosed with infantile colic

Interventions

  • DIETARY_SUPPLEMENT B. infantis EVC001 or Lactose Placebo

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2022-02-23
Est. Completion 2022-06-01
Phase NA
Evolve BioSystems

5 total trials

Why NCT05129384 stopped before completion

NCT05129384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which B. infantis EVC001 or Lactose Placebo is the first listed.

NCT05129384 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05129384 about?

NCT05129384 is a clinical study titled "The COLIC Study: Colonization of the Infant Gut With B. Infantis EVC001 to Reduce Symptoms of Colic". To investigate whether B. infantis EVC001 colonization in the infant gut can reduce symptoms of colic

What is the current status of trial NCT05129384?

This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2022-02-23. Estimated completion is 2022-06-01.

What interventions are being tested in trial NCT05129384?

The interventions under investigation include: B. infantis EVC001 or Lactose Placebo (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05129384?

This trial is sponsored by Evolve BioSystems, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05129384's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT05129384, the US trial registry maintained by the National Library of Medicine. NCT05129384 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.