Efficacy of the Enteroadsorbent Silicol®gel in Adults with Irritable Bowel Syndrome Subtypes IBS-D or Mixed: Observational Open-Label Study

Table 1

Full exclusion criteria.

	Any of the following criteria excluded subjects from study participation:
1	Having a significant acute or chronic coexisting illness (cardiovascular, endocrine, immunological, metabolic, or any condition which contraindicates, in the investigator’s judgment, entry into the study).
2	Having a diagnosis of inflammatory bowel disease, bowel cancer, coeliac disease, or any other bowel disease, which, in the opinion of the investigator, makes them unsuitable for entry into the study.
3	Any GI-related abdominal surgery other than hernia repair or appendectomy. Cholecystectomy more than 6 months previously is not an exclusion.
4	Individuals who have taken any antibiotics or oral steroids in the last 3 weeks.
5	Individuals planning to start any new medications during the course of the study
6	Known HIV infection, or hepatitis A, B, or C active infection.
7	Change in dose or introduction of an antipsychotic within the last month.
8	Have suffered from an uncontrolled or current major psychiatric disorder.
9	Individuals who, in the opinion of the investigator, are poor attendees or unlikely for any reason to be able to comply with the study requirements.
10	Subject is currently enrolled in or has not yet completed at least 30 days since ending another investigational device or drug study(s), or the patient is receiving another investigational agent(s).
11	Females who are pregnant or breastfeeding.
12	Unwilling or unable to comply with the study procedures. This includes leaving at least one hour between the ingestion of silicolgel and any other medication.
13	Taking a probiotic supplement and being unwilling to leave at least 1 hour between ingestion of IP and probiotic.
14	History of regular use of silicolgel or enterosgel for IBS.