Trial Outcomes & Findings for Effect of VSL#3 on Bone Mineral Density in Postmenopausal Women (NCT NCT03165747)

NCT ID: NCT03165747

Last Updated: 2020-03-04

Results Overview

All DEXA scans will be performed on the same device using a GE Lunar iDEXA machine. Participants will be asked to lie still on a scanning table with their arms at their sides for approximately 10 minutes.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: Baseline and 12-month visit.
• Results posted on: 2020-03-04

Participant Flow

Participants were recruited at Emory University Hospital in Atlanta, Georgia, USA. Enrollment began on October 1, 2017 and all study activity stopped on March 23, 2019.

35 individuals consented to participate. The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

Participant milestones

Measure	VSL#3 Participants randomized to receive two sachets of the VSL#3 probiotic, taken orally daily in a single administration.	Placebo Participants randomized to receive two placebo sachets, taken orally daily in a single administration.
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of VSL#3 on Bone Mineral Density in Postmenopausal Women

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Baseline and 12-month visit.

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

All DEXA scans will be performed on the same device using a GE Lunar iDEXA machine. Participants will be asked to lie still on a scanning table with their arms at their sides for approximately 10 minutes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and 12-month visit.

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

All DEXA scans will be performed on the same device using a GE Lunar iDEXA machine. Participants will be asked to lie still on a scanning table with their arms at their sides for approximately 10 minutes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-month, 12-month visits

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-month, 12-month visits

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-month, 12-month visits

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-month, 12-month visits

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-month, 12-month visits

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 6-month, 12-month visits

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

Up to approximately 50 mL of fasted blood will be collected at every visit from a peripheral vein.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every two weeks during the study 12-months

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

This will be determined by contacts (twice monthly telephone or at research center visits) of the study coordinator with each subject and responses to three standardized question areas: 1) "Are you having any difficulty, problems or new symptoms with the study medication?" 2) If yes, "What has the problem been?" and 3) "Have you missed any of your study drug doses, and if so how many in the previous 2 week period?" Appropriate notations based on subject responses will be documented in the case report form (CRF). Subjects will be instructed at study entry and reminded via serial contacts to return all of their used and unused drug sachets at each research center visit. Unused and used study drug sachets will be tallied and recorded in the CRF by the study coordinator serially for the entire study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every two weeks during the study 12-months

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

Study drug tolerance will be assessed by obtaining serial measures of the Gastrointestinal Symptom Rating Scale (GSRS). These will be obtained with in-person interviews at the baseline and month 6 and 12 visits and by telephone contact with all subjects by the study coordinator every 2 weeks. Data will be analyzed within the 5 symptom domains depicting symptoms related to gastric reflux, abdominal pain, indigestion, diarrhea, and constipation.The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. A GSRS total score, the sum of all 5 domains, will also be assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: The investigational product became the subject of a court judgment upholding false advertising claims concerning the product's similarity to earlier products sold under the same name. Because of questions raised by this ruling, no participants are considered as being assigned to a protocol-defined study arm.

The number of participants who complete all study visits, phone calls, and maintain drug compliance. Retention will be documented via conventional Consolidated Standards of Reporting Trials (CONSORT) criteria and documentation of missed study visits, missed telephone communications and compliance with study drug administration. All data will be maintained in the CRFs.

Outcome measures

Outcome data not reported

Adverse Events

VSL#3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Roberto Pacifici, MD

Emory University

Phone: 404-712-8420

Email: roberto.pacifici@emory.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place