Encapsulation of Lactobacillus rhamnosus bacteria

Early Phase 1

Conditions: Constipation and gastrointestinal cancer.
Gastrointestinal tract NOS
C26.9

Registration Number: IRCT20230105057061N1

Lead Sponsor: Islamic Azad University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Male

Target Recruitment: 25

Inclusion Criteria

The main conditions for entering the study before randomization: patients will be selected based on the Rome II criteria according to the diagnosis of digestive and liver diseases; (Rome II criteria: abdominal pain or any digestive discomfort for at least 3 months during a year) The past three months can be consecutive or non-consecutive, along with two of the following three: resolution of pain with defecation, onset of symptoms with change in frequency of defecation, onset of symptoms with change in stool shape) minimum age 18 years of informed consent of the patient, which is adopted in writing after providing all the necessary explanations for them.

Exclusion Criteria

The main conditions of non-entry into the study before randomization: a history of major gastrointestinal surgery, chronic use of antibiotics, corticosteroids, and immunosuppressive drugs, regular use of drugs that change the movements of the digestive system, such as metoclopramide, cisapride, domperidone, narcotics, especially Opioid derivatives, laxative agents, antidiarrheal agents, and other drugs effective in the treatment of IBS, which are described in more detail in the text. The presence of severe mental and behavioral disorders in the patient, the presence of food allergies, the presence of any organic intestinal disease or chronic digestive disease

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abdominal pain intensity. Timepoint: At the beginning of the study (before the start of the intervention) and at the end of the study (the end of the intervention) during the intervention and 3 months after the intervention. Method of measurement: Questionnaire (numbers 0 to 10 to check pain intensity, where 0 represents the absence of pain and 10 represents very intense pain).;. Timepoint: . Method of measurement: .

Secondary Outcome Measures

Name	Time	Method
Albumin and pre-albumin. Timepoint: Before the intervention, during the intervention and 3 months after the intervention. Method of measurement: Laboratory kits.;Alkaline phosphatase. Timepoint: Before the intervention, during the intervention and 3 months after the intervention. Method of measurement: Laboratory kits.;Alanine aminotransferase. Timepoint: Before the intervention, during the intervention and 3 months after the intervention. Method of measurement: Laboratory kits.;Erythrocyte sedimentation rate (ESR). Timepoint: Before the intervention, during the intervention and 3 months after the intervention. Method of measurement: Laboratory kits.