Evaluation of Multi-strain Lactobacillus Capsule on Gastric Emptying Function by Tc-99m Scintigraphy in a Crossover Placebo-Controlled Clinical Trial
YUH-FENG WANG1,2#, HSIN-YU HUANG3,4#, YUNG-WEI CHIU5,6, WEI-HSUN CHAO4, TZYY-LING CHUANG1, YING-CHEN LU7 AND MEEI-YN LIN3*
1. Department of Nuclear Medicine, DalinTzuChi GeneralHospital, Chiayi, Taiwan, R.O.C.
2. School of Medicine, TzuChiUniversity, Hualien, Taiwan, R.O.C.
3. Department of Food Science and Biotechnology, NationalChungHsingUniversity, Taichung , Taiwan, R.O.C.
4. Department of Early Childhood Educare, Wu Feng University, Chiayi, Taiwan, R.O.C.
5. Institute of Medicine, ChungShanMedicalUniversity, Taichung, Taiwan, R.O.C.
6. Emergency Department and Hyperbaric OxygenTherapyCenter, Tungs’ TaichungMetroHarborHospital, Taichung, Taiwan, R.O.C.
7. Department of Food Science, National Chiayi University, Taiwan, R.O.C.
(Received: October 21, 2011; Accepted: April 27, 2012)
ABSTRACT
Current pharmacological therapy for gastroparesis is limited by a few optional agents with high side effect profiles. Probiotics, which exert both prokinetic and antibiotic properties, can be a good alternative. This study investigates the effects of capsules containing three species of Lactobacillus on gastric emptying function by using a crossover placebo-controlled clinical trial. The 15 healthy participants recruited were divided into two groups, with one group of 7 persons aged between 20-40 and another group of 8 persons aged between 41-60. All the participants in each group were provided with placebo capsules and probiotic capsules, respectively, to be taken twice a day after meals for 3 weeks with crossover in the following 3 weeks. Tc-99m scintigraphy was performed at the beginning of weeks 0, 3 and 6 to determine the gastric emptying rate. All time-activity curves were constructed and the half time of gastric emptying (GEt1/2) was calculated for the same subject for comparison. The GEt1/2 of the baseline, placebo and Lactobacillus regimen periods for the 20-40 age group were 73.0 ± 16.0, 85.7 ± 10.5, and 87.8 ± 10.0 min, respectively, while those for the 41-60 age group were 79.1 ± 23.9, 70.9 ± 33.1, and 68.4 ± 15.2 min, respectively. Comparison of the two groups showed a positive effect of probiotics capsules on the 41 to 60-year-old participants (p = 0.013) but not on the 20 to 40-year-old participants. There was no significant statistical difference between the two groups in the period of treatment with placebo. This early stage trial indicated that the multi-strain Lactobacillus capsule is safe and the results provided some evidence that it accelerated gastric emptying in healthy adults above 40 years of age and may become a therapeutic approach in future trials for pathological gastric emptying delay, by implication, especially in diabetic gastroparesis.
Key words: Lactobacillus, gastric emptying, gastroparesis, scintigraphy clinical trial