Result :
Thirty patients participated in the study, 5 women and 25 men, and were randomly assigned to two groups. During the first 3 months, five patients voluntarily withdrew from the study (4 in the experimental group, one in the placebo group). We continued the study to the end with 25 patients, 5 women (20%) and 20 men (80%). Our groups included 56 and 44 percent of patients.
The average age of the remaining subjects was 41.4 years (30.8 years for women, 43.9 years for men) and the average duration of treatment with ART was 4.4 years.
Chart 1 shows how participants participated in each part of the study.(figure 1)
The mean CD4 count before administration of probiotics was 168.88 (SD =71.072) in all patients. After our first intervention, administration of placebo and probiotics for groups A and B, we observed a significant increase in CD4 count in group A compared with group B (mean of CD4 count changes: Group A=-20.4286, Group B=49.27, difference(A-B)=-69.70, CI(95%): (-97.96 ~ -41.43), p-value < 0.001).
In our second intervention, we exchanged the two groups and administered probiotics for group B and placebo for group A. Again, we observed a significant increase in CD4 counts in the probiotic group compared to the previous phase (mean of CD4 count changes: Group A=62.071, Group B=-36.81, Difference(A-B)=98.88, CI(95%): (70.66~127.11), p-value < 0.001).
Next, we examined the effect of probiotics on each group separately. We wanted to see how the beginning and the end of taking probiotics affected the CD4 count. In group A, administration of the placebo resulted in a decrease in CD4 count in the first three months (from 202.21 to 181.79, p-value < 0.001), which could be due to the natural history of the disease. After probiotics administration, CD4 count increased significantly (from 181.79 to 243.86, p-value < 0.001). Overall, after 6 months of study, there was a significant increase in mean CD count from 202.21 to 243.86 (p-value < 0.001).
In group B, administration of probiotics in the first three months of the study resulted in a significant increase in mean CD4 count (from 126.45 to 175.73, p-value < 0.001). Termination of treatment with probiotics resulted in a significant decrease (from 175.73 to 138.9, p-value < 0.001), but overall the CD4 count at the end of the study was significantly higher than at baseline (p-value < 0.001). (table 1 )
Our analyses on other variables such as age, gender, duration of treatment with ART and duration of disease did not reveal significant associations.
Table 1: mean CD4 changes in group A&B