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Does Intestinal microflora play a role in the symptom scores and life quality of people with Coeliac disease?

Phase 2
Completed
Conditions
Coeliac Disease
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Registration Number
ACTRN12610000630011
Lead Sponsor
Southern Cross University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
45
Inclusion Criteria

1.Participants who have had Coeliac disease confirmed by small bowel biopsy
2.Participants who have followed a gluten free diet for at least 12 months
3.At least 12 months since small bowel biopsy diagnosis

Exclusion Criteria

1.Pregnant women
2.Participants under the age of 18
3.Individuals with cancer or who are HIV positive
4.Patients who have been diagnosed with Coeliac disease in the past 12 months
5.Patients who consume a gluten containing diet
6.Individuals with gastrointestinal pathology such as cancer, Crohn’s disease or ulcerative colitis
7.Individuals with short bowel syndrome
8.Individuals who have had recent oral or bowel surgery
9.Individuals currently being treated with chemotherapy or radiotherapy
10.People who are using or have used non-steroidal or steroidal anti-inflammatory drugs, antibiotics, antipyretics or the oral contraceptive pill in the four weeks prior to the start of the trial
11.Individuals with serum urea, electrolytes and creatinine greater than 2 times the upper limit of normal at baseline
12.Individuals with liver function tests greater than 3 times the upper limit of normal at baseline
13.Participants unwilling to comply with the study protocol
14.Any other condition which, in the opinion of the investigators, could compromise the study
15.Individuals with active alcohol and or illicit drug dependence.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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