Familial adenomatous polyposis
Conditions
Interventions
Trade Name: Lithiumcarbonate
Product Name: Lithiumcarbonate
Product Code: 55991
Pharmaceutical Form: Tablet
Sponsors
Center for Experimental and Molecular Medicine, G2 (AMC)
Eligibility
Sex/Gender
All
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
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 |
|---|---|
| Main Objective: The aim of this study is to investigate the effect of low-dose Lithium on stem cell dynamics, the number and size of polyps and, to assess safety outcomes of this drug in FAP patients. ;Secondary Objective: /;Primary end point(s): - 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).;Timepoint(s) of evaluation of this end point: every 6 months (t=0m, t=6m, t=12m, t=18m) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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. ;Timepoint(s) of evaluation of this end point: every 6 months (t=0m, t=6m, t=12m, t=18m) | — |
Countries
Netherlands
Outcome results
None listed