NCT02351089

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

3.8 years

First QC Date

January 20, 2015

Last Update Submit

March 3, 2020

Conditions

Gastrointestinal ToxicityGynecologic Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in incidence of loose/watery stools

    Baseline and 10 weeks later

Study Arms (3)

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

Capsules placeboDIETARY_SUPPLEMENT

Capsules

Placebo
Capsules probiotic powder and corn starchDIETARY_SUPPLEMENT
Probiotic high doseProbiotic low dose

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Oncology

Lund, Sweden

Location

MeSH Terms

Interventions

Starch

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 30, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

March 5, 2020

Record last verified: 2020-03

Locations

SE(1)