NCT00844766

Brief Summary

The hypothesis underlying this study is that whilst there is no home-screening test for lactose intolerance, this test would have significant value as lactose tolerance tests and breath hydrogen tests are expensive and time consuming. Therefore, it would be highly beneficial to validate a simple home-screening test. This study will validate a simple home-screening test that uses lactose and not milk.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2006

Shorter than P25 for all trials

Status
withdrawn

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

Study Start

First participant enrolled

December 1, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

2 months

First QC Date

February 13, 2009

Last Update Submit

April 2, 2019

Conditions

Lactose Intolerance

Keywords

Lactose intoleranceLactoseHome-screening testValidate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with lactose intolerance

You may qualify if:

  • Diagnosed lactose intolerance as demonstrated by a lactose tolerance test
  • Diagnosed as not having lactose intolerance as demonstrated by a lactose tolerance test

You may not qualify if:

  • Pregnant
  • Breastfeeding
  • Unwillingness to comply with study outline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lactose Intolerance

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • John F Mayberry, DSc MD

    University Hospitals, Leicester

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 16, 2009

Study Start

December 1, 2006

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

April 4, 2019

Record last verified: 2019-04