Here is the design of a clinical trial:

Official Title: A Prospective, Randomised Placebo Controlled Feasibility Trial of Faecal Microbiota Transplantation in Cirrhosis

Included conditions:
- Cirrhosis of the Liver

Study Armgroups:
- {'label': 'Faecal microbiota transplantation', 'type': 'EXPERIMENTAL', 'description': 'Faecal microbiota transplantation.', 'interventionNames': ['Biological: Faecal microbiota transplantation']}
- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo solution.', 'interventionNames': ['Biological: Placebo']}

Interventions:
- {'type': 'BIOLOGICAL', 'name': 'Faecal microbiota transplantation', 'description': "The FMT (200mls) will be administered following preparation of the bowel with MoviPrep®, into the duodenum via a gastroscope derived from 50g of fresh donated stool from a healthy donor. The gastroscopy will be performed as per the King's College Hospital Gastroenterology Protocol.", 'armGroupLabels': ['Faecal microbiota transplantation']}
- {'type': 'BIOLOGICAL', 'name': 'Placebo', 'description': 'An identical appearing placebo solution (200mls 0.9% normal saline and 12.5% glycerol) will be administered into the duodenum via a gastroscope in a single blinded fashion following preparation of the bowel with MoviPrep®.', 'armGroupLabels': ['Placebo']}

Primary Outcomes:
- {'measure': 'Assessment of the feasibility of FMT', 'description': 'Assess recruitment rates and tolerability of FMT (e.g reflux rates):\n\n* \\>50% fulfil inclusion/exclusion criteria (of all screened- about 160)\n* \\>25% consent rate (of all those fulfilling inclusion/exclusion criteria about 80 patients)\n* \\>80% randomised patients treated successfully and completing study up to D90 (out of those randomised approx 22 patients)\n* Availability of obtaining sufficient donor samples for the study\n* Reflux rates of transplanted material \\<20% e.g. foul taste, foul smell, nausea, vomiting, indigestion.\n* Intolerable (resulting in withdrawal from the study GI side effects including diarrhoea, constipation, abdominal pain, flatulence and bloating) of \\<20%', 'timeFrame': '18 months'}
- {'measure': 'Assessment of the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'description': '1. Incidence of any transmissible bacterial or viral infection that is deemed to have been acquired from the donor including Clostridium Difficile infection\n2. The development of any SAE/SAR or USAR that is not pre-specified or is a known consequence of disease progression or complication of cirrhosis as outlined in section 7.2.5.1 that: results in death/is life threatening/requires hospitalisation or prolongation of existing hospitalisation/results in persistent or significant disability or incapacity.', 'timeFrame': '18 months'}

Please estimate the sample size based on the assumption: 
The study uses a 95% CI for feasibility parameters, aims for at least 80% power, and considers a 25% consent rate, 50% eligibility rate, and 80% completion rate. The significance level is not explicitly mentioned, but the precision of estimates is discussed.
Sample size
          This feasibility study will evaluate feasibility parameters using 95% CIs. The sample size has been proposed mainly to enable the trial to be conducted within the allocated budget and with acceptable precision for continuous outcomes. According to the simulation work by Teare et al,18 even with the relatively small pilot sample size of 20, the planned studies would have at least 80% power to detect the target effect size (for continuous outcomes) more than 75% of the time. Teare et al recommend that 60â100 subjects are sufficient to estimate an event rate (such as recruitment rates) with acceptable precision in a feasibility study, while sample sizes between 24 and 50 have been recommended for the accurate estimation of SDs. Therefore, we have chosen a sample size of 32 patients in this trial to have reliable data on all critical parameters (including event rates) which can also be usedÂ when planning a larger intervention trial. For event rates (eg, recruitment rates) and particularly in the extreme case with lower rates, forÂ example, 10%, we estimate a drop of precision by only 5% using our updated sample size and the minimum recommended by Teare et al (0.16 for 60 patients vs 0.21 for 32 patients). Figure 2 illustrates the reduction in precision of different rates when the sample size increases for binary outcomes. This sample size will also be feasible within the budget and will provide acceptable information for planning a future large clinical trial.
          
            Figure 2
            
              CI width around one proportion (P) by sample size (N) from PASS softwareÂ V.15.
            
            
          
          The sample size of 32 patients will undergo randomisation in a 3:1 ratio. This will allow the study to demonstrate theÂ feasibility of randomising, yet providing robust evidence with respect to the feasibility of the treatment and preliminary evidence of efficacy parameters.
          The following feasibility criteria have been established:Twenty-five per cent of screened patients will consent: 256 patients will allow the estimate of the two-sided 95% CI of the proportion of consented patients, where the distance from the observed proportion to the limit is 0.058 units.Fifty per cent of patients screened will fulfil inclusion/exclusion criteria for the trial: screening 64 patients will allow the estimate of the two-sided 95% CI of the proportion of patients eligible, where the distance from the observed proportion to the limit is 0.128 units.Eighty per cent of randomised patients will complete treatment and follow-up: 26 of 32 patients completing will allow the estimate of the two-sided 95% CI for a single proportion, where the distance from the observed proportion to the limit is 0.177 units.

          Differences between the placebo and treatment group in efficacy binary outcomes will be estimated along with the two-sided 95%âCIÂ (table 1). Assuming the proportion with the outcome in the control group is 0.5, our sample size will allow estimation of the half-width of the CIs for different size of differences as indicated below. Differences of 0.4 or higher will be distinguishable from 0.
          
            Table 1
            
              Half-width of CIs for differences in proportions between two groups with given sample size, placebo group, p=0.5 (created with PASS software REFâPASS V.15)
            
            
              
                
                  Difference
                  0.1
                  0.2
                  0.3
                  0.4
                  0.5
                
                
                  Width
                  0.398
                  0.392
                  0.382
                  0.337
                  0.347
                
              
            
            
              
                The half-width of the 95%âCI of the difference in means for continuous outcome will be 0.889 SD.