Mixture of Prebiotics on Intestinal Microbiota of Patients Receiving Abdominal Radiotherapy.

NCT01549782CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Hospital General Universitario Gregorio Marañon

Enrollment

40

Start Date

2005-06-01

Completion Date

2007-12-01

Study Type

INTERVENTIONAL

Official Title

Effect of a Mixture of Inulin and Fructo-oligosaccharide on Lactobacillus and Bifidobacterium Intestinal Microbiota of Patients Receiving Radiotherapy: a Randomised, Double-blind, Placebo-controlled Trial.

Interventions

Inulin and Fructo-oligosaccharideMaltodextrine

Conditions

PrebioticsMicrobiotaRadiation Therapy ComplicationEndometrial Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* female gender, age ≥ 18 years, and a diagnosis of gynaecologic cancer requiring postoperative pelvic RT.

Exclusion Criteria:

* previous RT, previous or adjuvant chemotherapy, other types of pelvic tumours or other gynaecologic malignancies, antibiotic or immunosuppressive treatment one week before inclusion or during treatment, and the presence of acute or chronic gastrointestinal disease contraindicating ingestion of the fibre

Outcome Measures

Primary Outcomes

Changes in Lactobacillus and Bifidobacterium populations

Time frame: 2 months

Secondary Outcomes

Changes in calprotectin and DNA levels.

Time frame: 2 months

Locations

Nutrition Unit. HGU Gregorio Marañón, Madrid, Spain

Mixture of Prebiotics on Intestinal Microbiota of Patients Receiving Abdominal Radiotherapy.