Probiotics in Radiation-treated Gynecologic Cancer | NCT02351089

Studies
Probiotics in Radiation-treated Gynecologic Cancer

NCT02351089

Sponsor

Probi AB

Status

Terminated

Last Update Posted

Mar 5, 2020Actual

Enrollment

97Actual

Phase

Not Applicable

Conditions

Gastrointestinal Toxicity
Gynecologic Cancer

Interventions

Capsules placebo
Capsules probiotic powder and corn starch

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow recruitment

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2019Actual

First Submitted Date

Jan 20, 2015

First Submission Date that Met QC Criteria

Jan 26, 2015

First Posted Date

Jan 30, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2020

Last Update Posted Date

Mar 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the current Project is to study the efficacy of a probiotic Product in reducing the symptoms of gastrointestinal toxicity linked to the irradiation of gynecologic cancer.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	capsules containing corn starch	Dietary Supplement: Capsules placebo
Probiotic low dose	Active Comparator	capsules containing probiotic powder and corn starch	Dietary Supplement: Capsules probiotic powder and corn starch
Probiotic high dose	Active Comparator	capsules containing probiotic powder and corn starch	Dietary Supplement: Capsules probiotic powder and corn starch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Capsules placebo	Dietary Supplement	Capsules	Placebo
Capsules probiotic powder and corn starch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in incidence of loose/watery stools		Baseline and 10 weeks later

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women diagnosed with cancer in the small pelvis and waiting to receive radiotherapy either as a primary or as a secondary treatment following surgery. Chemotherapy may or may not be part of the treatment regimen.
Age, older than 18 years old.
Agreement for participation in the study by signed written informed consent.

Exclusion Criteria:

Previously treated with irradiation of the pelvic area.
Reluctance to refrain from using other probiotic products during the participation in the study.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013213	Starch

Ancestor Terms

ID	Term
D005936	Glucans
D001704	Biopolymers
D011108	Polymers
D046911	Macromolecular Substances

Browse Leaves

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Browse Branches

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