familial adenomatous polyposis familial intestinal polyps
Conditions
Interventions
All patients will be treated with Lithium with an oral dose of 300mg a day for
six months, achieving a therapeutic serum level between 0.2-0.4 mmol/L.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Male or female between the age of 18 and 35 years; - Confirmed APC germline mutation; - Positive family history of a classical FAP phenotype (>100 colorectal adenomas); - Intact colon, with a minimum of 50 polyps; - Participant is willing and able to give informed consent for participation
Exclusion criteria
Exclusion criteria: - Participation in any other clinical intervention study; observational trials accepted; - Lithium use prior to participation of the study; - Pregnancy, breast-feeding or no use of anticonception; - No normal intestinal mucosa left for normal tissue biopsy; - Indication for colectomy within 2 years; - Known renal impairment, defined as GFR < 60 ml/min; - Known severe cardiac disorder; - Known severe brain injury; - Hypothyroidism; - Hyponatremia, defined as Na < 130mmol/L; - Positive family history of Brugada syndrome - Co-medication known for interacting with Lithium (as defined in the protocol). - Regular NSAID use (defined as more than twice a week for 4 consecutive weeks) within 3 months prior to baseline; - Use of immunosuppressive or anti-inflammatory drugs within 3 months prior to baseline; - Use of any other FAP directed drug therapy within 3 months prior to baseline (use of any alternative supplements e.g. turmeric or fish-oil must be noted in questionnaire).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Clone sizes will be quantified as proportions of the crypt circumference positive for NOTUM (in parts of eight, 1:8 to 8:8). When a whole crypt is positive for NOTUM (8:8), this crypt is fixed (crypt fixation). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Difference in number and size of polyps between baseline and end of study - Patient reported side effects of Lithium using a Lithium side effect questionnaire (see appendix 2 of the protocol) - Safety outcomes by analysing reported adverse events, physical examination and laboratory findings. | — |
Countries
Netherlands
Outcome results
None listed