Clinical Studies (Gastro-Intestinal & Associated Effects)

Gastro-intestinal and associated effects

Clinical trials performed in Japan with LACBON ⁶⁰ (L. sporogenes*)

Reports from various hospitals that performed clinical trials on groups of patients suffering from a variety of intestinal disorders and allergic skin diseases are summarized in Table 5.1.

It is evident that the administration of L. sporogenes* markedly improved the general clinical condition of the subjects and provided relief from intestinal disorders and allergic skin conditions. Allergic skin conditions can be related to an imbalance of intestinal flora66 in the subject. This condition was therefore corrected by L. sporogenes* therapy in these trials.
SUMMARY OF SELECTED CLINICAL REPORTS FROM JAPAN :
TRIALS WITH LACBON^Ò (L. sporogenes*)

1. Condition: Acute and chronic intestinal catarrh

No. of subjects: 38
Treatment: 100-600 million spores/ day in divided doses for 2-12 days
Effectiveness rate: 86.8%

Conclusion: Recovery from diarrhea to regular normal stools; general symptoms including anorexia improved
2. Condition: Diarrhea

No. of subjects: 15
Treatment: 75-600 million spores/ day in divided doses for 3-12 days
Effectiveness rate: 100%

Conclusion: Recovery from diarrhea to regular, normal stools from third to fourth day
3. Condition: Constipation

No. of subjects: 10
Treatment: 300-750 million spores / day in divided doses for 2-10 days
Effectiveness rate: 70.0%

Conclusion: Recovery to normal stools and disappearance of abdominal distention
4. Condition: Abnormal intestinal fermentation

No. of subjects: 9
Treatment: 300-600 million spores / day in divided doses for 3-14 days
Effectiveness rate: 100.0%

Conclusion: Vomiting and nausea disappeared; appetite improved; stools became normal and regular; diarrhea and stomach ache cured.
5. Condition: Dyspepsia infantum

No. of subjects: 26
Treatment: 100-200 million spores / day in divided doses for 1-7 days
Effectiveness rate: 84.6%

Conclusion: General conditions and nature of stools improved. Frequency of stools decreased to half or less than that before medication.
6. Condition: Allergic skin diseases

No. of subjects: 5
Treatment: 200-450 million spores / day in divided doses for 4-12 days
Effectiveness rate: 80.0%

Conclusion: Obvious eruptions of strophulus and eczema decreased from the third day (topical therapy employed concomitantly)
7. Condition: Miscellaneous symptoms

No. of subjects: 10
Treatment: 20-50 million spores / day in divided doses for 4-20 days
Effectiveness rate: 80.0%

Conclusion: Response seen in anorexia of nervous type and malnutrition in infants

The above data are cited from clinical reports by: Terumichi Kuniya, Pediatric Clinic of Shinko Hospital, Kobe; Jetsuo Nitta, Medical Clinic of Kugason Hospital; Goro Koide, Pediatric Clinic of Kanto Teishin Hospital; Michio Ogasawara, Medical Clinic of Kahoku Hospital; Susumu Nakazawa, Pediatric Clinic of Ebara Hospital.

Studies with SPORLAC^Ò (L. sporogenes*)⁵⁹ in India

A total of 60 cases of neonatal diarrhea with watery stool frequency greater than 6 were examined for efficacy of SPORLAC treatment. Based on the suggested dosage level of SPORLAC at 5 million spores per kilogram body weight, each neonate was given a spore level of about 15 million spores per day. Some of the subjects had associated symptoms in addition to diarrhea;

Jaundice 3

Septicemia 3

Cord Infection 3

Vomiting 3

Most of the subjects (about 80%) had a history of breast-feeding. About 19% were both breast and bottle-fed and 1% were bottle-fed.

The average duration for recovery was 1.8 days and the results of the study are tabulated:

Condition Cases treated Cases Cured Success rate

Diarrhea 60 49 81.7%

Constipation 3 3 100%

Jaundice 3 3 100%

As compared to the normal practice of administration of antibiotic and antidiarrheal mixtures, the complicating side effects were not seen in the series of SPORLAC trials. The average recovery time of 1.8 days helped to reduce dehydration in the subjects to a great extent.

In a similar study in Japan(cited in 59) a comparable success rate of 78.4% with SPORLAC treatment for infantile diarrhea was obtained. An earlier study in India by Mathur et al. (cited in 59) found the average time for improvement in diarrheal conditions to be two to three days, with treatment.

* The taxonomical classification was revised in 1939 in the seventh edition of the Bergey’s Manual of Determinative Bacteriology to B. coagulans, although some researchers continued to use the original name.