Trial Outcomes & Findings for Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults (NCT NCT02355210)

NCT ID: NCT02355210

Last Updated: 2021-11-23

Results Overview

change in microbiota composition, including presence of B. adolescentis BD1 and B. animalis supsp lactis BB-12

Recruitment status

COMPLETED

Study phase

Target enrollment

151 participants

Primary outcome timeframe

baseline and three weeks

Results posted on

2021-11-23

Participant Flow

151 subjects enrolled. Of these, 37 subjects discontinued trial prior to treatment randomization due to loss to follow-up (n=12), subject no longer interested (n=9), laboratory values outside range (n=5), and other (n=11).

Participant milestones

Participant milestones
Measure	Placebo 5 g lactose given as a placebo	Probiotic 1 Bifidobacteria adolescentis BD1, 10\^9	Probiotic 2 Bifidobacteria animalis subsp. lactis BB-12, 10\^9	Synbiotic 1 galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10\^9)	Synbiotic 2 galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10\^9)	Prebiotic galactooligosaccharide, 5 g
Overall Study STARTED	19	18	16	17	19	18
Overall Study COMPLETED	19	18	16	17	19	18
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=17 Participants 5 g lactose given as a placebo	Probiotic 1 n=14 Participants Bifidobacteria adolescentis BD1, 10\^9	Probiotic 2 n=14 Participants Bifidobacteria animalis subsp. lactis BB-12, 10\^9	Synbiotic 1 n=16 Participants galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10\^9)	Synbiotic 2 n=17 Participants galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10\^9)	Prebiotic n=16 Participants galactooligosaccaride, 5 g	Total n=94 Participants Total of all reporting groups
Age, Continuous	43.9 years STANDARD_DEVIATION 8.8 • n=5 Participants	44.7 years STANDARD_DEVIATION 13.3 • n=7 Participants	43.9 years STANDARD_DEVIATION 12.5 • n=5 Participants	44.2 years STANDARD_DEVIATION 11.8 • n=4 Participants	43.1 years STANDARD_DEVIATION 12.7 • n=21 Participants	45.9 years STANDARD_DEVIATION 9.6 • n=8 Participants	44.3 years STANDARD_DEVIATION 11.2 • n=8 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	12 Participants n=5 Participants	11 Participants n=4 Participants	12 Participants n=21 Participants	12 Participants n=8 Participants	69 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	4 Participants n=8 Participants	25 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	9 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	14 Participants n=4 Participants	15 Participants n=21 Participants	15 Participants n=8 Participants	85 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity · White	5 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	31 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity · African American	10 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	13 Participants n=4 Participants	11 Participants n=21 Participants	11 Participants n=8 Participants	58 Participants n=8 Participants
Race/Ethnicity, Customized Ethnicity · Other	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants
Region of Enrollment United States	17 participants n=5 Participants	14 participants n=7 Participants	14 participants n=5 Participants	16 participants n=4 Participants	17 participants n=21 Participants	16 participants n=8 Participants	94 participants n=8 Participants
Education Less than or equal to 12 years	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	6 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants	20 Participants n=8 Participants
Education Greater than 12 years	14 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	10 Participants n=4 Participants	15 Participants n=21 Participants	10 Participants n=8 Participants	74 Participants n=8 Participants

PRIMARY outcome

Timeframe: baseline and three weeks

Population: Mann-Whitney-Wilcoxon matched pair tests

change in microbiota composition, including presence of B. adolescentis BD1 and B. animalis supsp lactis BB-12

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants 5 g lactose given as a placebo	Probiotic 1 n=14 Participants Bifidobacteria adolescentis BD1, 10\^9	Probiotic 2 n=14 Participants Bifidobacteria animalis subsp. lactis BB-12, 10\^9	Synbiotic 1 n=16 Participants galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10\^9)	Synbiotic 2 n=17 Participants galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10\^9)	Prebiotic n=16 Participants galactooligosaccharide, 5 g
Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 Bifidobacterium Baseline	7.9 percentage of bacterial taxa Standard Deviation 8.1	9.1 percentage of bacterial taxa Standard Deviation 5.3	8.8 percentage of bacterial taxa Standard Deviation 5.7	6.0 percentage of bacterial taxa Standard Deviation 5.9	8.7 percentage of bacterial taxa Standard Deviation 6.2	11.3 percentage of bacterial taxa Standard Deviation 10.5
Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 Bifidobacterium Treatment End	12.0 percentage of bacterial taxa Standard Deviation 8.0	14.6 percentage of bacterial taxa Standard Deviation 6.9	9.5 percentage of bacterial taxa Standard Deviation 8.4	14.7 percentage of bacterial taxa Standard Deviation 7.4	15.9 percentage of bacterial taxa Standard Deviation 8.0	17.4 percentage of bacterial taxa Standard Deviation 11.4
Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 OTU_1 (B adolescentis) Baseline	1.2 percentage of bacterial taxa Standard Deviation 1.9	1.2 percentage of bacterial taxa Standard Deviation 4.2	1.2 percentage of bacterial taxa Standard Deviation 2.5	2.5 percentage of bacterial taxa Standard Deviation 4.5	3.1 percentage of bacterial taxa Standard Deviation 4.5	3.8 percentage of bacterial taxa Standard Deviation 7.5
Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 OTU_1 (B adolescentis) Treatment End	2.6 percentage of bacterial taxa Standard Deviation 4.1	3.4 percentage of bacterial taxa Standard Deviation 5.1	1.1 percentage of bacterial taxa Standard Deviation 1.6	7.3 percentage of bacterial taxa Standard Deviation 7.0	6.8 percentage of bacterial taxa Standard Deviation 9.6	6.6 percentage of bacterial taxa Standard Deviation 8.8
Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 OTU_167 (B. animalis subsp. lactis) Baseline	0.0 percentage of bacterial taxa Standard Deviation 0.0	0.0 percentage of bacterial taxa Standard Deviation 0.0	0.0 percentage of bacterial taxa Standard Deviation 0.0	0.0 percentage of bacterial taxa Standard Deviation 0.0	0.0 percentage of bacterial taxa Standard Deviation 0.0	0.0 percentage of bacterial taxa Standard Deviation 0.0
Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12 OTU_167 (B. animalis subsp. lactis) Treatment End	0.0 percentage of bacterial taxa Standard Deviation 0.1	0.0 percentage of bacterial taxa Standard Deviation 0.0	0.1 percentage of bacterial taxa Standard Deviation 0.1	0.0 percentage of bacterial taxa Standard Deviation 0.0	0.1 percentage of bacterial taxa Standard Deviation 0.2	0.2 percentage of bacterial taxa Standard Deviation 0.9

PRIMARY outcome

Timeframe: baseline and three weeks

Change in intestinal permeability as measured by change in percent sugars in urine

Outcome measures

Outcome measures
Measure	Placebo n=17 Participants 5 g lactose given as a placebo	Probiotic 1 n=14 Participants Bifidobacteria adolescentis BD1, 10\^9	Probiotic 2 n=14 Participants Bifidobacteria animalis subsp. lactis BB-12, 10\^9	Synbiotic 1 n=16 Participants galacto-oligosaccharide (5 g) and Bifidobacteria adolescentis BD1 (10\^9)	Synbiotic 2 n=17 Participants galacto-oligosaccharide (5 g) and Bifidobacteria animalis subsp. lactis BB-12 (10\^9)	Prebiotic n=16 Participants galactooligosaccharide, 5 g
Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine Sucralose:Lactulose with aspirin Baseline	0.32 sucralose:lactulose ratio Standard Deviation 0.20	0.34 sucralose:lactulose ratio Standard Deviation 0.21	0.34 sucralose:lactulose ratio Standard Deviation 0.30	0.32 sucralose:lactulose ratio Standard Deviation 0.23	0.36 sucralose:lactulose ratio Standard Deviation 0.19	0.37 sucralose:lactulose ratio Standard Deviation 0.19
Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine Sucralose:Lactulose with aspirin Treatment End	0.36 sucralose:lactulose ratio Standard Deviation 0.25	0.20 sucralose:lactulose ratio Standard Deviation 0.16	0.26 sucralose:lactulose ratio Standard Deviation 0.18	0.20 sucralose:lactulose ratio Standard Deviation 0.16	0.29 sucralose:lactulose ratio Standard Deviation 0.16	0.23 sucralose:lactulose ratio Standard Deviation 0.15

SECONDARY outcome

Timeframe: baseline and three weeks

Endotoxemia, as measured by change in circulating endotoxin by lipopolysaccharide and lipopolysaccharide-binding protein