Effect of Oral Intake of Lactiplantibacillus plantarum APsulloc 331261 (GTB1 TM ) on Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study

Irritable bowel syndrome (IBS) causes intestinal discomfort, gut dysfunction, and poor quality of life. This randomized, double-blind placebo-controlled trial evaluated the efficacy of ( ., formerly ) APsulloc 331261 (GTB1 ) from green tea leaves in participants with diarrhea-predominant irritable b...

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Published in:Nutrients Vol. 14; no. 10; p. 2015
Main Authors: Jung, Kyoungmi, Kim, Areum, Lee, Ji-Hae, Cho, Donghyun, Seo, Juyeon, Jung, Eun Sung, Kang, Hye-Ji, Roh, Jonghwa, Kim, Wangi
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Published: Switzerland MDPI AG 11-05-2022
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Abstract Irritable bowel syndrome (IBS) causes intestinal discomfort, gut dysfunction, and poor quality of life. This randomized, double-blind placebo-controlled trial evaluated the efficacy of ( ., formerly ) APsulloc 331261 (GTB1 ) from green tea leaves in participants with diarrhea-predominant irritable bowel syndrome (IBS-D). Twenty-seven participants meeting the Rome IV diagnostic criteria were randomized for GTB1 or placebo ingestion for four weeks and follow-up for two weeks. The efficacy endpoints included adequate global relief of symptoms, assessment of intestinal discomfort symptom severity and frequency, stool frequency, satisfaction, and fecal microbiome abundance. Of all participants, 94.4% and 62.5% reported global relief of symptoms in the GTB1 and placebo groups, respectively, with significant differences ( = 0.037). GTB1 significantly reduced the severity and frequency of abdominal pain, bloating, and feeling of incomplete evacuation. The frequencies of diarrhea were decreased -45.89% and -26.76% in the GTB1 and placebo groups, respectively ( = 0.045). Hence, GTB1 ingestion improved IBS-D patient quality of life. After four weeks treatment, the relative abundance of was higher in the GTB1 than in the placebo group ( = 0.010). Our results showed that GTB1 enhanced intestinal discomfort symptoms, defecation consistency, quality of life, beneficial microbiota, and overall intestinal health.
AbstractList Irritable bowel syndrome (IBS) causes intestinal discomfort, gut dysfunction, and poor quality of life. This randomized, double-blind placebo-controlled trial evaluated the efficacy of Lactiplantibacillus (Lp., formerly Lactobacillus) plantarum APsulloc 331261 (GTB1TM) from green tea leaves in participants with diarrhea-predominant irritable bowel syndrome (IBS-D). Twenty-seven participants meeting the Rome IV diagnostic criteria were randomized for GTB1 or placebo ingestion for four weeks and follow-up for two weeks. The efficacy endpoints included adequate global relief of symptoms, assessment of intestinal discomfort symptom severity and frequency, stool frequency, satisfaction, and fecal microbiome abundance. Of all participants, 94.4% and 62.5% reported global relief of symptoms in the GTB1 and placebo groups, respectively, with significant differences (p = 0.037). GTB1 significantly reduced the severity and frequency of abdominal pain, bloating, and feeling of incomplete evacuation. The frequencies of diarrhea were decreased −45.89% and −26.76% in the GTB1 and placebo groups, respectively (p = 0.045). Hence, GTB1 ingestion improved IBS-D patient quality of life. After four weeks treatment, the relative abundance of Lactobacillus was higher in the GTB1 than in the placebo group (p = 0.010). Our results showed that GTB1 enhanced intestinal discomfort symptoms, defecation consistency, quality of life, beneficial microbiota, and overall intestinal health.
Irritable bowel syndrome (IBS) causes intestinal discomfort, gut dysfunction, and poor quality of life. This randomized, double-blind placebo-controlled trial evaluated the efficacy of ( ., formerly ) APsulloc 331261 (GTB1 ) from green tea leaves in participants with diarrhea-predominant irritable bowel syndrome (IBS-D). Twenty-seven participants meeting the Rome IV diagnostic criteria were randomized for GTB1 or placebo ingestion for four weeks and follow-up for two weeks. The efficacy endpoints included adequate global relief of symptoms, assessment of intestinal discomfort symptom severity and frequency, stool frequency, satisfaction, and fecal microbiome abundance. Of all participants, 94.4% and 62.5% reported global relief of symptoms in the GTB1 and placebo groups, respectively, with significant differences ( = 0.037). GTB1 significantly reduced the severity and frequency of abdominal pain, bloating, and feeling of incomplete evacuation. The frequencies of diarrhea were decreased -45.89% and -26.76% in the GTB1 and placebo groups, respectively ( = 0.045). Hence, GTB1 ingestion improved IBS-D patient quality of life. After four weeks treatment, the relative abundance of was higher in the GTB1 than in the placebo group ( = 0.010). Our results showed that GTB1 enhanced intestinal discomfort symptoms, defecation consistency, quality of life, beneficial microbiota, and overall intestinal health.
Irritable bowel syndrome (IBS) causes intestinal discomfort, gut dysfunction, and poor quality of life. This randomized, double-blind placebo-controlled trial evaluated the efficacy of Lactiplantibacillus ( Lp ., formerly Lactobacillus ) plantarum APsulloc 331261 (GTB1 TM ) from green tea leaves in participants with diarrhea-predominant irritable bowel syndrome (IBS-D). Twenty-seven participants meeting the Rome IV diagnostic criteria were randomized for GTB1 or placebo ingestion for four weeks and follow-up for two weeks. The efficacy endpoints included adequate global relief of symptoms, assessment of intestinal discomfort symptom severity and frequency, stool frequency, satisfaction, and fecal microbiome abundance. Of all participants, 94.4% and 62.5% reported global relief of symptoms in the GTB1 and placebo groups, respectively, with significant differences ( p = 0.037). GTB1 significantly reduced the severity and frequency of abdominal pain, bloating, and feeling of incomplete evacuation. The frequencies of diarrhea were decreased −45.89% and −26.76% in the GTB1 and placebo groups, respectively ( p = 0.045). Hence, GTB1 ingestion improved IBS-D patient quality of life. After four weeks treatment, the relative abundance of Lactobacillus was higher in the GTB1 than in the placebo group ( p = 0.010). Our results showed that GTB1 enhanced intestinal discomfort symptoms, defecation consistency, quality of life, beneficial microbiota, and overall intestinal health.
Author Seo, Juyeon
Kang, Hye-Ji
Roh, Jonghwa
Lee, Ji-Hae
Kim, Areum
Kim, Wangi
Jung, Eun Sung
Jung, Kyoungmi
Cho, Donghyun
AuthorAffiliation 2 HEM PHARMA Inc., Suwon-si 16229, Gyeonggi-do, Korea; esjung@hempharma.bio (E.S.J.); hjkang@hempharma.bio (H.-j.K.)
3 Global Green Research Development Center, Handong Global University, Pohang-si 37554, Gyeongbuk, Korea
1 Amorepacific Research and Innovation Center, Yongin-si 17074, Gyeonggi-do, Korea; areumkim@amorepacific.com (A.K.); seavet@amorepacific.com (J.-H.L.); cdh0529@amorepacific.com (D.C.); yeon8687@amorepacific.com (J.S.); rohjh@amorepacific.com (J.R.); katemina@amorepacific.com (W.K.)
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– name: 2 HEM PHARMA Inc., Suwon-si 16229, Gyeonggi-do, Korea; esjung@hempharma.bio (E.S.J.); hjkang@hempharma.bio (H.-j.K.)
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Keywords Lactiplantibacillus plantarum APsulloc 331261 (GTB1)
green tea
irritable bowel syndrome
diarrhea
Language English
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Snippet Irritable bowel syndrome (IBS) causes intestinal discomfort, gut dysfunction, and poor quality of life. This randomized, double-blind placebo-controlled trial...
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StartPage 2015
SubjectTerms Abdomen
Clinical trials
Constipation
Defecation
Diarrhea
Diarrhea - etiology
Dietary supplements
Discomfort
Double-Blind Method
Double-blind studies
Feces
Green tea
Homeostasis
Humans
Ingestion
Intestine
Irritable Bowel Syndrome
Lactiplantibacillus plantarum APsulloc 331261 (GTB1)
Lactobacillus
Lactobacillus plantarum
Microbiomes
Microbiota
Pain
Physiology
Placebos
Probiotics
Quality of Life
Relative abundance
Tea
Treatment Outcome
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Title Effect of Oral Intake of Lactiplantibacillus plantarum APsulloc 331261 (GTB1 TM ) on Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study
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