Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510978
Status:
UNKNOWN
Last Update Posted:
2011-06-14
First Post:
2007-08-02
Brief Title:
Probiotics in GastroIntestinal Disorders
Sponsor:
University College Cork
Organization:
University College Cork
Study Overview
Official Title:
One Year Randomised Double Blind Placebo Controlled Trial of Probiotics Bifidobacterium Infantis 35624 or Lactobacillus Salivarius UCC118 as Food Supplements for Maintenance of Remission in Crohns Disease and Ulcerative Colitis
Status:
UNKNOWN
Status Verified Date:
2007-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROGID
Brief Summary:
All of us have millions of bacteria living in our gut These bacteria are very important to our health providing us with protection against infections of the gut allowing us to gain extra nutritional value from food we eat and helping our immune system Changes in the balance of these many bacteria can make us vulnerable to infections both from within and from outside the gut Certain bacteria may also be directly associated with some diseases of the gut Research by doctors and scientists into relationships between the bacteria normally found in our gut and certain diseases of the gut is helping to develop food supplements and other therapies to treat these diseases
This study involves research into the usefulness and safety of two probiotic products in maintaining remission in Crohns disease and ulcerative colitis Approximately 360 patients with Crohns disease and ulcerative colitis from Ireland Finland and Spain will be involved in the study The yoghurts used in this study contain either Lactobacillus salivarius subsp salivarius or Bifidobacterium infantis
This study involves research into the usefulness and safety of two probiotic products in maintaining remission in Crohns disease and ulcerative colitis Approximately 360 patients with Crohns disease and ulcerative colitis from Ireland Finland and Spain will be involved in the study The yoghurts used in this study contain either Lactobacillus salivarius subsp salivarius or Bifidobacterium infantis
Detailed Description:
There is a growing body of evidence that the enteric bacterial flora contribute to the pathogenesis of inflammatory bowel disease IBD Crohns disease and Ulcerative Colitis Targan S and Shanahan F Inflammatory Bowel Disease From Bench to Bedside Williams and Wilkins 1994
It has recently been found that patients suffering active Crohns disease have significantly less recoverable bifidobacteria in their faeces compared to healthy individuals This reduction in bifidobacteria numbers was observed to be directly correlated with decreased levels of B-D-galactosidase production and activity Favier C et al Dig Dis Sci 199742817-822 B-D-galactosidase is an enzyme produced by bifidobacteria These results support suggestions proposed in other studies Bartram HP et al Am J Clin Nutr 199459428-432 that strains of bifidobacteria may play important roles in maintaining a balanced healthy intestinal microflora
In Crohns disease there is extensive clinical evidence indicating the importance of the continuity of the faecal stream in disease recurrence
Ingestion of bifidobacteria can improve gastrointestinal transit In elderly individuals mild constipation can be at least partially corrected through the consumption of milk fermented by bifidobacteria Seki M et al Nutr Food 19784379-387 In addition colonic transit times of women were significantly accelerated in the sigmoid colon following consumption of a milk fermented by bifidobacteria sp and yoghurt cultures Grimaud JC et al Gastroenterol Clin Biol 199317A127 but not by traditional yoghurt cultures alone Grimaud JC et al Les bact_ries lactiques 1994406
Several genetically engineered knock out and transgenic animal models of IBD have been reported in which the role of the enteric flora has been directly demonstrated by comparing animals raised in germ free versus conventional facilities For example the gastrointestinal Crohns-like inflammation that occurs in interleukin-10 IL-10 deficient mice is attenuated when the animals are kept in a germ free environment and becomes more pronounced and widespread when they are switched to conventional facilities Kuhn R et al Cell 199375263-274
The mucosal inflammation in IL-10 deficient mice has been reported to be reduced by feeding the animals a preparation of lactobacilli Madsen K et al Gastroenterology 1997112A1030 a result subsequently confirmed by a UCC-based research group who also reported that consumption of Lactobacillus salivarius UCC118 reduced cancer incidence OMahony et al2001
Studies completed in rats have demonstrated that ingestion of bifidobacteria can suppress aberrant crypt foci early preneoplastic lesions formation in the colon Kulkarni N and Reddy B Proc Soc Experim Biol Med 1994207278-283 in addition to significant decreases in colon tumor incidence and in the numbers of tumors present Singh J et al Carcinogenesis 199718833-841
Background and Preliminary data
Several probiotic strains of lactic acid bacteria and Bifidobacterium probiotic strains have been developed in UCC
Lactobacillus salivarius UCC118 was chosen for its probiotic potential based on in vitro activity against several pathogens and several other properties including acidbile tolerance In addition a preliminary trial approved by the UCC Ethics Committee has already been conducted in 80 human volunteers and has shown that either milk or yoghurt may be used as a vehicle for delivery of Lactobacillus salivarius UCC118 to the gastrointestinal tract with equal efficacy in altering gut flora and apparent colonisation An abstract based on this study has been submitted to the American Gastroenterological Association and a full manuscript has been submitted for publication
Furthermore administration of Lactobacillus UCC118 to 20 patients with relapsed Crohns disease over a six week period resulted in reports that consumption of the probiotic improved patient quality of life and in fact in most cases patients avoided the requirement for steroid use McCarthy et al Submitted
Bifidobacterium infantis 35624 was chosen for its probiotic potential based on several physiological properties including acidbile tolerance In addition preliminary trials completed by the UCC probiotic research group in collaboration with UCLA School of Medicine Division of Digestive Diseases have shown that Bifidobacterium infantis 35624 or a combination of Lactobacillus salivarius UCC118 and Bifidobacterium infantis 35624 may prove more effective in beneficially altering gut flora in an inflammatory disease mouse model and of alleviating the symptoms of IBD in colonised mice An abstract based on this study has been submitted to the American Gastroenterological Association and a full manuscript is in preparation
The primary aim of the study is to determine whether ingestion of probiotic preparations containing Lactobacillus salivarius subsp salivarius UCC118 or Bifidobacterium infantis 35624 can help in the maintenance of remission of patients with Crohns disease and ulcerative colitis over a period of one year ie delay the onset of relapse
Secondary aims include an evaluation of the immunological and biochemical parameters of the immuno-inflammatory response and an assessment of the faecal flora in patients consuming the probiotic and control products
It has recently been found that patients suffering active Crohns disease have significantly less recoverable bifidobacteria in their faeces compared to healthy individuals This reduction in bifidobacteria numbers was observed to be directly correlated with decreased levels of B-D-galactosidase production and activity Favier C et al Dig Dis Sci 199742817-822 B-D-galactosidase is an enzyme produced by bifidobacteria These results support suggestions proposed in other studies Bartram HP et al Am J Clin Nutr 199459428-432 that strains of bifidobacteria may play important roles in maintaining a balanced healthy intestinal microflora
In Crohns disease there is extensive clinical evidence indicating the importance of the continuity of the faecal stream in disease recurrence
Ingestion of bifidobacteria can improve gastrointestinal transit In elderly individuals mild constipation can be at least partially corrected through the consumption of milk fermented by bifidobacteria Seki M et al Nutr Food 19784379-387 In addition colonic transit times of women were significantly accelerated in the sigmoid colon following consumption of a milk fermented by bifidobacteria sp and yoghurt cultures Grimaud JC et al Gastroenterol Clin Biol 199317A127 but not by traditional yoghurt cultures alone Grimaud JC et al Les bact_ries lactiques 1994406
Several genetically engineered knock out and transgenic animal models of IBD have been reported in which the role of the enteric flora has been directly demonstrated by comparing animals raised in germ free versus conventional facilities For example the gastrointestinal Crohns-like inflammation that occurs in interleukin-10 IL-10 deficient mice is attenuated when the animals are kept in a germ free environment and becomes more pronounced and widespread when they are switched to conventional facilities Kuhn R et al Cell 199375263-274
The mucosal inflammation in IL-10 deficient mice has been reported to be reduced by feeding the animals a preparation of lactobacilli Madsen K et al Gastroenterology 1997112A1030 a result subsequently confirmed by a UCC-based research group who also reported that consumption of Lactobacillus salivarius UCC118 reduced cancer incidence OMahony et al2001
Studies completed in rats have demonstrated that ingestion of bifidobacteria can suppress aberrant crypt foci early preneoplastic lesions formation in the colon Kulkarni N and Reddy B Proc Soc Experim Biol Med 1994207278-283 in addition to significant decreases in colon tumor incidence and in the numbers of tumors present Singh J et al Carcinogenesis 199718833-841
Background and Preliminary data
Several probiotic strains of lactic acid bacteria and Bifidobacterium probiotic strains have been developed in UCC
Lactobacillus salivarius UCC118 was chosen for its probiotic potential based on in vitro activity against several pathogens and several other properties including acidbile tolerance In addition a preliminary trial approved by the UCC Ethics Committee has already been conducted in 80 human volunteers and has shown that either milk or yoghurt may be used as a vehicle for delivery of Lactobacillus salivarius UCC118 to the gastrointestinal tract with equal efficacy in altering gut flora and apparent colonisation An abstract based on this study has been submitted to the American Gastroenterological Association and a full manuscript has been submitted for publication
Furthermore administration of Lactobacillus UCC118 to 20 patients with relapsed Crohns disease over a six week period resulted in reports that consumption of the probiotic improved patient quality of life and in fact in most cases patients avoided the requirement for steroid use McCarthy et al Submitted
Bifidobacterium infantis 35624 was chosen for its probiotic potential based on several physiological properties including acidbile tolerance In addition preliminary trials completed by the UCC probiotic research group in collaboration with UCLA School of Medicine Division of Digestive Diseases have shown that Bifidobacterium infantis 35624 or a combination of Lactobacillus salivarius UCC118 and Bifidobacterium infantis 35624 may prove more effective in beneficially altering gut flora in an inflammatory disease mouse model and of alleviating the symptoms of IBD in colonised mice An abstract based on this study has been submitted to the American Gastroenterological Association and a full manuscript is in preparation
The primary aim of the study is to determine whether ingestion of probiotic preparations containing Lactobacillus salivarius subsp salivarius UCC118 or Bifidobacterium infantis 35624 can help in the maintenance of remission of patients with Crohns disease and ulcerative colitis over a period of one year ie delay the onset of relapse
Secondary aims include an evaluation of the immunological and biochemical parameters of the immuno-inflammatory response and an assessment of the faecal flora in patients consuming the probiotic and control products
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| QLK1-CT-2000-00563 | None | None | None |