Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432608
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-09
Brief Title:
Efficacy of Lacticaseibacillus Paracasei Strain Shirota on Clinical Manifestation of Functional Constipation in Mexican Adults
Sponsor:
University of Guadalajara
Organization:
University of Guadalajara
Study Overview
Official Title:
Single Arm Study to Evaluate the Efficacy of Lacticaseibacillus Paracasei Strain Shirota Formerly Lactobacillus Casei Strain Shirota Fermented Milk Yakult on the Maintenance of Clinical Manifestations of Functional Constipation in Mexican Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
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:
FC
Brief Summary:
Chronic functional constipation is a gastrointestinal disorder with an approximate prevalence of 14 of the Mexican population which is characterized by difficult or incomplete defecation andor infrequent bowel movements with the absence of symptoms such as abdominal pain or inflammation and in If they occur they should not be the predominant symptoms Its origin is multifactorial and includes variables such as diet water consumption alteration in motility and intestinal microbiota the latter as a source of different secondary metabolites such as short-chain fatty acids SCFAs
Lower SCFA values in constipation would alter the relationship between them increasing the risk of clinical manifestations of functional chronic constipation In addition to physical discomfort subjects with this disease manifest alterations in their quality of life
Recent studies have suggested using probiotic microorganisms to treat this functional disorder due to their beneficial effects on evacuation frequency SCFAs and quality of life However in Mexico knowledge of the above is limited Therefore this research aims to determine the effect of consuming a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota on the clinical manifestations of functional constipation in Mexican adults and its relationship with SCFAs
Lower SCFA values in constipation would alter the relationship between them increasing the risk of clinical manifestations of functional chronic constipation In addition to physical discomfort subjects with this disease manifest alterations in their quality of life
Recent studies have suggested using probiotic microorganisms to treat this functional disorder due to their beneficial effects on evacuation frequency SCFAs and quality of life However in Mexico knowledge of the above is limited Therefore this research aims to determine the effect of consuming a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota on the clinical manifestations of functional constipation in Mexican adults and its relationship with SCFAs
Detailed Description:
1 Background
Constipation is an intestinal disorder characterized by difficulty defecating infrequent bowel movements hard or lumpy stools excessive straining a feeling of incomplete evacuation and in some cases the use of manual techniques to facilitate evacuation
Due to its presentation time constipation is classified as acute or chronic The acute one lasts less than a week and is commonly determined by a change in diet andor lifestyle low fiber intake decreased physical activity stress going to the bathroom in an unknown place etc For its part the symptoms of chronic illness have occurred over three to six months Chronic constipation is among the most common gastrointestinal conditions usually primary or secondary The first is a consequence of multiple pathophysiological alterations such as alteration of colonic regulation lack of coordination of the neuromuscular apparatus and dysfunction of the brain-gut axis In turn secondary chronic constipation can be caused by drugs neurological disorders anatomical processes or metabolic diseases
Chronic constipation is defined from a clinical point of view chronic constipation is considered secondary when it is a consequence of metabolic neurological alterations structural lesions or medications When other causes have been excluded it is considered primary idiopathic or functional constipation FD
11 Clinical manifestations
Chronic constipation is a functional gastrointestinal disorder with a prevalence of 3 to 27 mainly among women and older adults Approximately 1 in 6 individuals experience chronic constipation The Mexican Consensus on chronic constipation mentions a prevalence of 144 in Mexicans while other studies carried out in the country have reported a prevalence between 24 and 223
This pathology is considered a syndrome with different symptoms that are expressed variably For this reason the ROMA Rome Foundation for Functional Gastrointestinal Problems criteria have been used to diagnose functional chronic constipation In 2016 the ROMA criteria updated their guidelines currently in version IV and included eight categories A esophageal disorders B gastroduodenal disorders C intestinal disorders D gastrointestinal pain of centrally median disorders E disorders of the sphincter of Oddi and the gallbladder F anorectal disorders G functional gastrointestinal disorders of childhood and G functional gastrointestinal disorders of adolescence Functional intestinal disorders are defined by these criteria which allow us to differentiate the symptoms of patients with chronic functional constipation from those with similar clinical conditions such as irritable bowel syndrome
In the ROME IV criteria chronic functional constipation is a disorder characterized by persistent or incomplete difficult defecation andor infrequent bowel movements without symptoms such as abdominal pain andor inflammation or if present that are not the predominant symptoms The Bristol scale supports the criteria in which grades 1 and 2 correspond to constipation and correlate with prolonged intestinal transit
12 Constipation and short-chain fatty acids
Chronic constipation is a multifactorial process influenced by diet stool volume water content and intestinal microbiota In recent years it has been considered that alterations in the balance of the intestinal microbiota may influence the clinical manifestations of chronic constipation It has been reported that the intestinal microbiota of constipated patients differs from that of healthy adults and children with a decrease in the genera Lactobacillus and Bifidobacterium Studies with gnotobiotic animals and in vitro have suggested that the intestinal microbiota influences intestinal motility the integrity of the intestinal barrier the modulation of colonic pH and the immune or nervous response through the production of short-chain fatty acids butyrate propionate and acetate
13 Constipation and probiotics
Patients with constipation usually have a prolonged intestinal transit time compared to healthy subjects decreasing evacuation frequency and stool consistency To achieve this laxatives dietary fiber supplements and the prescription of some drugs are used as treatment However in recent years the use of probiotics has been considered due to the impact of their consumption on the intestinal microbiotametabolites and in turn on gastric motility
It has been reported that consuming 108 to 3 x 1010 CFU per day of specific probiotic strains improves intestinal transit increases evacuation frequency and improves symptoms related to constipation Studies with Lacticaseibacillus paracasei strain Shirota LcS in the Chinese population showed improvement in the frequency and consistency of fecal matter and reduced intestinal discomfort The intake of probiotics improves intestinal transit and increases the levels of organic acids that promote peristalsis It also increases the Bifidobacterium and Lactobacillus genera which are usually in lower abundance in constipation Probiotics could not only directly improve intestinal discomfort but also through the formation of secondary metabolites of the intestinal microbiota such as short-chain fatty acids
Therefore probiotics such as Lacticaseibacillus paracasei strain Shirota have begun to be studied in murine models and in the Asian population as a non-pharmacological alternative for functional chronic constipation However its effect on the Mexican population with constipation requires more evidence as does the relationship between the intake of probiotics in functional constipation and short-chain fatty acids
2 General objective
To evaluate the efficiency of Lacticaseibacillus paracasei strain Shirota Shirota formerly Lactobacillus casei strain Shirota in fermented milk Yakult on the maintenance of the clinical manifestations of functional constipation in Mexican adults
3 Hypothesis
The consumption of a product based on milk fermented with Lacticaseibacillus paracasei strain Shirota has an effect on the maintenance of the clinical manifestations of functional constipation in Mexican adults
4 Methodology
An original longitudinal analytical and prospective quasi-experimental study in adults diagnosed with functional chronic constipation under the ROME IV criteria is planned The study will provide a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota for four weeks Before consuming the product a baseline analysis of SCFAs will be carried out in fecal matter As part of the techniques and procedures height and weight will be measured using the ISAK methodology to obtain the body mass index BMI Meanwhile the clinical manifestations of evacuation frequency and consistency of fecal matter will be evaluated considering the ROME IV criteria with visual support from the Bristol and symptom severity scales The analysis of short-chain fatty acids will be done by gas chromatography whose signal will be compared with an internal standard
Constipation is an intestinal disorder characterized by difficulty defecating infrequent bowel movements hard or lumpy stools excessive straining a feeling of incomplete evacuation and in some cases the use of manual techniques to facilitate evacuation
Due to its presentation time constipation is classified as acute or chronic The acute one lasts less than a week and is commonly determined by a change in diet andor lifestyle low fiber intake decreased physical activity stress going to the bathroom in an unknown place etc For its part the symptoms of chronic illness have occurred over three to six months Chronic constipation is among the most common gastrointestinal conditions usually primary or secondary The first is a consequence of multiple pathophysiological alterations such as alteration of colonic regulation lack of coordination of the neuromuscular apparatus and dysfunction of the brain-gut axis In turn secondary chronic constipation can be caused by drugs neurological disorders anatomical processes or metabolic diseases
Chronic constipation is defined from a clinical point of view chronic constipation is considered secondary when it is a consequence of metabolic neurological alterations structural lesions or medications When other causes have been excluded it is considered primary idiopathic or functional constipation FD
11 Clinical manifestations
Chronic constipation is a functional gastrointestinal disorder with a prevalence of 3 to 27 mainly among women and older adults Approximately 1 in 6 individuals experience chronic constipation The Mexican Consensus on chronic constipation mentions a prevalence of 144 in Mexicans while other studies carried out in the country have reported a prevalence between 24 and 223
This pathology is considered a syndrome with different symptoms that are expressed variably For this reason the ROMA Rome Foundation for Functional Gastrointestinal Problems criteria have been used to diagnose functional chronic constipation In 2016 the ROMA criteria updated their guidelines currently in version IV and included eight categories A esophageal disorders B gastroduodenal disorders C intestinal disorders D gastrointestinal pain of centrally median disorders E disorders of the sphincter of Oddi and the gallbladder F anorectal disorders G functional gastrointestinal disorders of childhood and G functional gastrointestinal disorders of adolescence Functional intestinal disorders are defined by these criteria which allow us to differentiate the symptoms of patients with chronic functional constipation from those with similar clinical conditions such as irritable bowel syndrome
In the ROME IV criteria chronic functional constipation is a disorder characterized by persistent or incomplete difficult defecation andor infrequent bowel movements without symptoms such as abdominal pain andor inflammation or if present that are not the predominant symptoms The Bristol scale supports the criteria in which grades 1 and 2 correspond to constipation and correlate with prolonged intestinal transit
12 Constipation and short-chain fatty acids
Chronic constipation is a multifactorial process influenced by diet stool volume water content and intestinal microbiota In recent years it has been considered that alterations in the balance of the intestinal microbiota may influence the clinical manifestations of chronic constipation It has been reported that the intestinal microbiota of constipated patients differs from that of healthy adults and children with a decrease in the genera Lactobacillus and Bifidobacterium Studies with gnotobiotic animals and in vitro have suggested that the intestinal microbiota influences intestinal motility the integrity of the intestinal barrier the modulation of colonic pH and the immune or nervous response through the production of short-chain fatty acids butyrate propionate and acetate
13 Constipation and probiotics
Patients with constipation usually have a prolonged intestinal transit time compared to healthy subjects decreasing evacuation frequency and stool consistency To achieve this laxatives dietary fiber supplements and the prescription of some drugs are used as treatment However in recent years the use of probiotics has been considered due to the impact of their consumption on the intestinal microbiotametabolites and in turn on gastric motility
It has been reported that consuming 108 to 3 x 1010 CFU per day of specific probiotic strains improves intestinal transit increases evacuation frequency and improves symptoms related to constipation Studies with Lacticaseibacillus paracasei strain Shirota LcS in the Chinese population showed improvement in the frequency and consistency of fecal matter and reduced intestinal discomfort The intake of probiotics improves intestinal transit and increases the levels of organic acids that promote peristalsis It also increases the Bifidobacterium and Lactobacillus genera which are usually in lower abundance in constipation Probiotics could not only directly improve intestinal discomfort but also through the formation of secondary metabolites of the intestinal microbiota such as short-chain fatty acids
Therefore probiotics such as Lacticaseibacillus paracasei strain Shirota have begun to be studied in murine models and in the Asian population as a non-pharmacological alternative for functional chronic constipation However its effect on the Mexican population with constipation requires more evidence as does the relationship between the intake of probiotics in functional constipation and short-chain fatty acids
2 General objective
To evaluate the efficiency of Lacticaseibacillus paracasei strain Shirota Shirota formerly Lactobacillus casei strain Shirota in fermented milk Yakult on the maintenance of the clinical manifestations of functional constipation in Mexican adults
3 Hypothesis
The consumption of a product based on milk fermented with Lacticaseibacillus paracasei strain Shirota has an effect on the maintenance of the clinical manifestations of functional constipation in Mexican adults
4 Methodology
An original longitudinal analytical and prospective quasi-experimental study in adults diagnosed with functional chronic constipation under the ROME IV criteria is planned The study will provide a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota for four weeks Before consuming the product a baseline analysis of SCFAs will be carried out in fecal matter As part of the techniques and procedures height and weight will be measured using the ISAK methodology to obtain the body mass index BMI Meanwhile the clinical manifestations of evacuation frequency and consistency of fecal matter will be evaluated considering the ROME IV criteria with visual support from the Bristol and symptom severity scales The analysis of short-chain fatty acids will be done by gas chromatography whose signal will be compared with an internal standard
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None