## Protocol Section
### Identification Module
**NCT ID:** NCT05432479

**Acronym:** PIXAR

**Brief Title:** Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

**Official Title:** A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief

#### Organization Study ID Info
**ID:** PCTB202010
#### Organization
**Class:** INDUSTRY
**Full Name:** The Archer-Daniels-Midland Company
### Status Module
#### Completion Date
**Date:** 2023-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2022-06-30

**Type:** ACTUAL

**Last Update Submit Date:** 2022-06-27

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2023-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-07

**Type:** ESTIMATED

**Status Verified Date:** 2022-05

#### Study First Post Date
**Date:** 2022-06-27
**Type:** ACTUAL
**Study First Submit Date:** 2022-06-21
**Study First Submit QC Date:** 2022-06-21
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Atlantia Food Clinical Trials

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** The Archer-Daniels-Midland Company

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.

### Conditions Module

**Conditions:**

- Infantile Colic

**Keywords:**

- probiotic

- Bifidobacterium

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Arm receiving investigation product (probiotic)

**Intervention Names:**

- Dietary Supplement: Probiotic

**Label:** Active

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Arm receiving placebo

**Intervention Names:**

- Dietary Supplement: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Active

**Description:** Single strain probiotic in a form of a sachets with a daily dose of 1.0E+9 Colony Forming Unit (CFU) per day for 4 weeks

**Name:** Probiotic

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Placebo

**Name:** Placebo

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Other Outcomes

**Description:** Change in maternal QoL using WHO QOL/BREF (improvement marked by increase in the total score)

**Measure:** Change in maternal quality of life and mental health

**Time Frame:** Day 0, Day 28

**Description:** Change in maternal QoL using MMPP/QoL (improvement marked by increase in the total score)

**Measure:** Change in maternal quality of life and mental health

**Time Frame:** Day 0, Day 28

#### Primary Outcomes

**Description:** eDiary parent reported cry and fuss time

**Measure:** Change in cry and fuss time

**Time Frame:** Day 0 , Day 28

#### Secondary Outcomes

**Description:** Reduction of cry and fuss time (parent reported) greater than 90% comparing to baseline

**Measure:** Resolution of colic symptoms

**Time Frame:** Day 0, Day 28

**Description:** eDiary parent reported cry and fuss bouts

**Measure:** Change in cry and fuss time bouts

**Time Frame:** Day 0, Day 28

**Description:** eDiary parent reported sleep time

**Measure:** Change in sleeping time

**Time Frame:** Day 0 Day 28

**Description:** Change in the proportion of participants needing to use rescue medications between the study arms

**Measure:** Change in the use of rescue medications

**Time Frame:** Day 0, Day 28

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Gestational age of minimum 37 weeks.
* Birthweight of minimum 2500 g (5.5 lb.).
* Age of greater than 3 weeks and less than 12 weeks at enrolment.
* Confirmed Infantile colic defined as: parental report of crying and/or fussing ≥3 hours/day for ≥3 days/week, confirmed prior to enrolment with an infant behaviour diary recording \>3 hours of crying in a 24-hour period (eDiary App completed daily during run-in period \& for duration of study).
* Participant Informed Consent form signed by parent or legal guardian.
* Infant is considered healthy following physical exam.
* Parents/Caregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits

Exclusion Criteria:

* Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial.
* Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics).
* Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).
* Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract.
* Failure to thrive.
* Known lactose or gluten intolerance.
* Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo.
* Known other causes for abdominal pain (e.g., pyloric stenosis).
* Participation in any other interventional clinical study.
* Immuno-compromised participant or participant with other severe chronic disorder.
* Use of probiotic supplements by breastfeeding mother from child's birth to enrolment.
* Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial.
* Any Participant/Parent/Caregiver who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.

**Maximum Age:** 12 Weeks

**Minimum Age:** 3 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007232

- Term: Infant, Newborn, Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6313

- Name: Colic

- Relevance: HIGH

- As Found: Infantile Colic

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003085

- Term: Colic

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T367

- Name: Bifidobacterium

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
