Gut Microbiota and Colonic Gene Expression: A Lignan Trial in Humans
Part 1 (Screening):
Potential participants submit a screening questionnaire for eligibility. Eligible
participants will come for an orientation for Part 1. If they consent the study coordinator
will measure their height and weight and give them all the materials to do the activities
for Part 1.
1. Stool sample
2. Days 1-3: take a lignan pill for three days
3. Day 3: 24-hour urine collection.
No all participants will be eligible for Part 2.
Part 2 (Trial):
Eligible participants will come for an orientation and consent.
1. 3-day food record
2. Stool sample
3. Fasting blood draw.
4. Colon cleanse (at home). 2 months- no study activities Period 1,
1. Day 0: Stool sample 2. Day 0: 24-h urine collection 3. Take study capsule daily for 2
months. 4. Day 54: Stool sample 5. Day 54: 24-hour urine 6. Day 55: Fasting blood draw 7.
Day 60 Sigmoidoscopy with biopsies 2 months- no study activities Period 2
1. Day 0: Stool sample
2. Day 0: 24-h urine collection
3. Take the other study capsule daily for 2 months.
4. Day 54: Stool sample
5. Day 54: 24-hour urine
6. Day 55: Fasting blood draw
7. Day 60 Sigmoidoscopy with biopsies
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
mRNA expression in colonic mucosal tissue (stroma and epithelial) and exfoliated cells in individuals with low- or high-ENL excretion.
Johanna Lampe, PhD Rd
Fred Hutchinson Cancer Research Center
United States: Institutional Review Board
FHCRC IR 7532
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