Trial Outcomes & Findings for Anti-anxiety Biotics for Breast Cancer Survivors (NCT NCT04784182)

NCT ID: NCT04784182

Last Updated: 2023-08-24

Results Overview

Number of Participants who were accrued in 6 months

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

6 months

Results posted on

2023-08-24

Participant Flow

No pre-assignment activities. Participants were randomized and received intervention or treatment immediately after baseline data collection was completed.

Participant milestones

Participant milestones
Measure	Synbiotic Supplement Group Daily consumption of pills containing prebiotics and probiotics probiotic plus prebiotic supplement: Daily consumption of probiotic containing at least 5 billion CFU per day total bacteria including Lactobacillus helveticus and Bifidobacterium longum and prebiotic containing 4 grams of fructooligosaccharides (FOS)	Placebo Group Daily consumption of pills containing maltodextrin placebo: Daily consumption of visually similar placebo pills
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Anti-anxiety Biotics for Breast Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Synbiotic Supplement Group n=1 Participants Daily consumption of pills containing prebiotics and probiotics probiotic plus prebiotic supplement: Daily consumption of probiotic containing at least 5 billion CFU per day total bacteria including Lactobacillus helveticus and Bifidobacterium longum and prebiotic containing 4 grams of fructooligosaccharides (FOS)	Placebo Group n=2 Participants Daily consumption of pills containing maltodextrin placebo: Daily consumption of visually similar placebo pills	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Age, Continuous	55 years n=93 Participants	62.5 years n=4 Participants	60 years n=27 Participants
Sex: Female, Male Female	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	1 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants
Generalized Anxiety Disorder Screener (GAD-7) Score	8 units on a scale (min=0; max=21) n=93 Participants	8 units on a scale (min=0; max=21) STANDARD_DEVIATION 4.24 • n=4 Participants	8 units on a scale (min=0; max=21) STANDARD_DEVIATION 3.0 • n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Number of Participants who were accrued in 6 months

Number of Participants who were accrued in 6 months

Outcome measures

Outcome measures
Measure	Synbiotic Supplement Group n=1 Participants Daily consumption of pills containing prebiotics and probiotics probiotic plus prebiotic supplement: Daily consumption of probiotic containing at least 5 billion CFU per day total bacteria including Lactobacillus helveticus and Bifidobacterium longum and prebiotic containing 4 grams of fructooligosaccharides (FOS)	Placebo Group n=2 Participants Daily consumption of pills containing maltodextrin placebo: Daily consumption of visually similar placebo pills
Feasibility - Accrual	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: All participants analyzed

Retain 85% of randomized participants for duration of study (6 weeks)

Outcome measures

Outcome measures
Measure	Synbiotic Supplement Group n=1 Participants Daily consumption of pills containing prebiotics and probiotics probiotic plus prebiotic supplement: Daily consumption of probiotic containing at least 5 billion CFU per day total bacteria including Lactobacillus helveticus and Bifidobacterium longum and prebiotic containing 4 grams of fructooligosaccharides (FOS)	Placebo Group n=2 Participants Daily consumption of pills containing maltodextrin placebo: Daily consumption of visually similar placebo pills
Feasibility - Retention	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 4 weeks

80% of participants consuming pills on 90% of intervention days

Outcome measures

Outcome measures
Measure	Synbiotic Supplement Group n=1 Participants Daily consumption of pills containing prebiotics and probiotics probiotic plus prebiotic supplement: Daily consumption of probiotic containing at least 5 billion CFU per day total bacteria including Lactobacillus helveticus and Bifidobacterium longum and prebiotic containing 4 grams of fructooligosaccharides (FOS)	Placebo Group n=2 Participants Daily consumption of pills containing maltodextrin placebo: Daily consumption of visually similar placebo pills
Feasibility - Adherence	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Outcome cannot be reported. Identification of age and race in baseline characteristics with total sample of n=3 compromises personally identifiable information.

Decrease in Generalized Anxiety Disorder-7 (GAD-7) score, which ranges from 0 (no anxiety) to 21 (severe anxiety).