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