NCT01303484

Brief Summary

The purpose of this study is to determine the effects of prebiotic B-GOS on the immune function, metabolism and gut microbiota of elderly people

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started May 2011

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

February 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

1.5 years

First QC Date

February 23, 2011

Last Update Submit

March 24, 2016

Conditions

Immunosenescence

Outcome Measures

Primary Outcomes (3)

  • Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers

    12 months

  • Effect of B-GOS on the faecal microbiota composition of elderly persons

    12 months

  • Effect of aging on body metabolites using NMR

    12 months

Secondary Outcomes (2)

  • Effect of B-GOS on gut permeability

    12 months

  • Weekly assessment of stools and gastrointestinal symptoms

    8 months

Study Arms (2)

MDn

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Maltodextrin

B-GOS

ACTIVE COMPARATOR

Prebiotic

Dietary Supplement: Bi2muno® GOS

Interventions

Bi2muno® GOSDIETARY_SUPPLEMENT

5.5g/day for 10 weeks

Also known as: galactooligosaccharide
B-GOS
MaltodextrinDIETARY_SUPPLEMENT

5.5g daily for 10 weeks

Also known as: Dextrin
MDn

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged between 65 and 80 years of age.
  • In good general health
  • The volunteer has given written informed consent to participate and is willing to participate in the entire study.

You may not qualify if:

  • History or evidence of disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years.
  • Family history of colorectal cancer in under 50's
  • Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.
  • Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous 6 months, or intention to use such drugs during the course of the study (please note sensory evaluations are still permitted).
  • Undergone surgical resection of any part of the bowel.
  • History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
  • Smoker
  • Lactose intolerant
  • Allergic to gluten
  • Currently prescribed immunosuppressive drugs. Participants will be required to withdraw should they begin taking any of the ineligible medication.
  • Intention to use regularly other medication which affects gastrointestinal motility and/or perception.
  • History of alcohol or drug misuse.
  • Suffer from any major conditions involving the following:
  • Head, Ears, Eyes, Nose and Throat Dermatological/Connective tissue Coeliac disease Neurological Lymphatic Urogenital/Rectal Gastroenterological Abdominal Respiratory Cardiovascular Incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, United Kingdom

Location

MeSH Terms

Interventions

4'-galactooligosaccharidemaltodextrinDextrins

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Glenn Gibson, PhD

    University of Reading, United Kingdom

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2011

First Posted

February 24, 2011

Study Start

May 1, 2011

Primary Completion

November 1, 2012

Study Completion

July 1, 2014

Last Updated

March 25, 2016

Record last verified: 2016-03

Locations

GB(1)