Aliveda

Clinical Study on Irritable Bowel Syndrome

In the context of irritable bowel syndrome, and gastro-intestinal disorders in general, Aliveda has invested time and resources in order to develop products that can alleviate these disorders.

These investments have allowed us to pursue collaborations with numerous medical specialists and experts in this field.

Today, we would like to talk about a clinical study, carried out on 123 patients suffering from IBS, by some of Aliveda’s collaborating doctors. [1]

The study :
123 patients suffering from IBS were enrolled in this study.
The clinical parameters analysed were:

Stool consistency, with the Bristol Stool Scale as the method of measurement
Pain symptomatology, measured with the VAS scale
Three assessments were performed for each individual patient:

T0 = at the time of enrolment and thus before treatment;

T1 = 2 weeks after the start of treatment

T4 = 4 weeks after the start of treatment

Treatment’ is defined as taking 1 capsule of Colircon, our IBS-specific product, for 4 weeks.

Clinical scales:
Before we talk about the results, we would like to better outline what the clinical parameters we mentioned above represent.

The Bristol Stool scale is a subjective scale that allows the patient, independently, to assess his or her own situation regarding bowel regularity and stool consistency.

This scale has 7 classes, with scores ranging from 1 to 7 and allows patients to be divided into:

Patients with typical alvus = score 1 and 2
Patients with normal alvus = score 3 and 4
Patients with diarrhoeal bowel = score 5, 6 and 7

The extremes represent the most critical situations, while the centre of the scale represents the normal situation.

The VAS scale for the assessment of pain symptoms is another subjective scale with scores from 1 to 10. Higher scores indicate a worse situation and thus a higher perception of pain.

Results:
The enrolled patients were divided as follows: 46 men and 77 women with an average age of approximately 52 years.

Table I shows the initial situation with regard to the Bristol Stool Scale and the VAS Scale.

Table I. Initial status of patients enrolled in the study
Subject: Request for confirmation of volume delivery

As can be seen from the table, 20% of the patients had ‘normal’ bowel for the Bristol Stool Scale with a score of about 3.5, in line with the classes seen previously.

30% were constipated, with an average score of 1.48, also representative of the scale seen above.

As many as 53.6% of patients were found to have a diarrhoeal condition, with a score of 6.5, also in line with the Bristol Stool Scale.

With regard to pain, the mean value of all patients was 6.7 out of 10, and thus representative of significant pain for IBS patients.

After treatment with Colicron :
After 4 weeks of treatment, i.e. one capsule a day of Colicron, the results confirmed the effectiveness of this product with great confidence.

Table II shows the final situation with regard to the Bristol Stool Scale and the VAS scale.

Table II. Final condition of patients enrolled in the study.

Comparing the two tables, it can be seen that after only 4 weeks of treatment, the percentage of patients with normal alvus increased from 16% to 77%, underlining Colicron’s great ability to positively regulate this very important parameter for IBS patients.

In Figure 1, we can observe graphically how the proportions of patients in the 3 groups (“Normal, Constipated, Diarrhoeal) changed during treatment (T0, T1 and T2), according to the Bristol Stool Scale. We can see how the proportion of “Normal” patients progressively increased.

Figure 1. Proportions of ‘Normal’, ‘Constipated’ and ‘Diarrhoeal’ patients during the 3 times (T0, T1 and T2) according to the Bristol Stool Scale.

The pain symptomatology parameter, i.e. the VAS scale, also decreased from an average value of 6.7 to 2.8, indicating a considerable reduction in pain with the use of Colicron.

Conclusions

This study demonstrated that Colicron is able to normalise two of the most important symptoms of IBS, i.e. altered bowel movement and regularity and pain perception.

The results therefore confirmed the efficacy of Colicron, underlining the quality of the formulation and basic research behind Aliveda’s product.

Further studies have been carried out and we will have the opportunity to share them with you in future articles.

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