Trial Outcomes & Findings for The Probiotic Study: Using Bacteria to Calm Your Mind (NCT NCT02711800)

Results Overview

Child and parent report is used to obtain ratings of pain frequency, the number of distinct occasions that pain was reported. Frequency was obtained for a one-week period pre and post intervention, and measured 3 times daily during these intervals. During the 30-day intervention, end of day frequencies were made. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. The average number of episodes across these time points will be calculated pre and post treatment. The change in this average frequency from pre to post treatment will be the measure of change.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)

Results posted on

2019-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	Lactobacillus Rhamnosus The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
Overall Study STARTED	9
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Lactobacillus Rhamnosus The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Data was missing for 3 participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactobacillus Rhamnosus n=9 Participants The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
Age, Continuous	11.746 years STANDARD_DEVIATION 0.753 • n=9 Participants
Sex: Female, Male Female	4 Participants n=9 Participants
Sex: Female, Male Male	5 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	3 Participants n=9 Participants
Race (NIH/OMB) White	6 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Pain intensity	1.11 units on a scale STANDARD_DEVIATION 1.04 • n=6 Participants • Data was missing for 3 participants

PRIMARY outcome

Timeframe: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)

Population: Data was missing for one participant

Child and parent report is used to obtain ratings of pain intensity on a 0-12 scale. A lower score equates to lower pain intensity. Ratings are obtained for a one-week period pre and post intervention, and measured 3 times daily. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. All time points will be averaged and combined across raters (child and parent) resulting in an average pain severity rating pre and post-treatment. The change in this average rating will be assessed as pain severity outcome. This measure was averaged with the pain frequency average score (see Primary Outcome 2) to result in one primary severity/frequency pain rating pre and post treatment. The change in this combined measure is our primary index of change.

Outcome measures

Outcome measures
Measure	Lactobacillus Rhamnosus n=6 Participants The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
Change in Child Abdominal Pain Rating	0.36 units on a scale Standard Deviation 0.58

PRIMARY outcome

Timeframe: One week pre-intervention (Study Day 1), One week post-intervention (Study Day 44)

Population: Data was missing for one participant

Child and parent report is used to obtain ratings of pain frequency, the number of distinct occasions that pain was reported. Frequency was obtained for a one-week period pre and post intervention, and measured 3 times daily during these intervals. During the 30-day intervention, end of day frequencies were made. Pre-treatment assessments took place days 1-7, participants were treated days 8-36, and post-intervention assessments were completed days 37-44. The average number of episodes across these time points will be calculated pre and post treatment. The change in this average frequency from pre to post treatment will be the measure of change.

Outcome measures

Outcome measures
Measure	Lactobacillus Rhamnosus n=6 Participants The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
Change in Child Abdominal Pain Frequency	0.40 pain episodes Standard Deviation 0.61

PRIMARY outcome

Timeframe: Baseline and 30 days

We report the change in magnitude of self-reported state anxiety derived from summed raw scores obtained through the six-item short-form of the state scale of the Spielberger State-Trait Anxiety Inventory at baseline and 30 days from baseline. Scores in the scale range from 6-24, with greater scores indicating worse anxiety. We obtained the summed raw scores after reverse scoring items 1, 4 \& 5.

Outcome measures

Outcome measures
Measure	Lactobacillus Rhamnosus n=7 Participants The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
Change in Child Anxiety Symptoms	1.30 units on a scale Standard Deviation 3.91

SECONDARY outcome

Timeframe: 30 days

Adherence was calculated as: ("the days probiotic was taken"/"total number of days of treatment") x 100, with results ranging from 0% (no probiotics taken at all) to 100% (probiotics taken 30 days out of the 30 day-treatment period). Researcher will subtract the number of pills/packets taken from the total amount.

Outcome measures

Outcome measures
Measure	Lactobacillus Rhamnosus n=7 Participants The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
Percentage of Adherence to Treatment	91 percentage of adherence Interval 77.0 to 100.0

SECONDARY outcome

Timeframe: Baseline and 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 30 days

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 30 days

Population: Three participants excluded from analysis: 2 with no post-treatment data, 1 with neither pre- nor post-treatment data.

Outcome measures

Outcome measures
Measure	Lactobacillus Rhamnosus n=6 Participants The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
Change in Salivary Cortisol (ug/dL)	-0.02 ug/dl Standard Deviation 0.06

SECONDARY outcome

Timeframe: Baseline and 30 days

Beats per minute (Bpm)

Outcome measures

Outcome measures
Measure	Lactobacillus Rhamnosus n=7 Participants The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by Dr. Patrick Seed from the department of pediatrics. The intervention duration is 30 days.
Change in Heart Rate	0.825 Beats per minute Standard Deviation 6.056

Adverse Events

Lactobacillus Rhamnosus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy Zucker

Duke University

Phone: 9196680075

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place