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D003248: Constipation

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug3025 PDS-08 Wiki 1.00
drug2061 Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Wiki 1.00
drug3195 Placebo Wiki 0.04

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D012817 Signs and Symptoms, Digestive NIH 1.00

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002019 Constipation HPO 1.00

Clinical Trials

Navigate: Correlations   HPO

There is one clinical trial.


1 A 12-week Randomized, Double-Blind Controlled Trial to Evaluate the Tolerability and Gastrointestinal Response of a Novel, Multi-Strain Synbiotic (PDS-08™) in Children Ages 3-17

Recent data support the use of specific probiotic strains in a pediatric population. However, given the wide number of commercial products available, and contradictory data in the literature, healthcare providers and consumers are uncertain about whether or not to use probiotics in children and which one(s) to choose. While much progress has been made in understanding the gastrointestinal microbiota and its role in the balanced development of the infant immune system, the tolerability and efficacy of introducing beneficial microbes into the pediatric gastrointestinal tract remain underexplored. The purpose of this study is to investigate the effect of a 9 strain synbiotic consortium comprised of strains with previous pediatric clinical data for use in modulating airway sensitivity, gastrointestinal discomfort, dermatological inflammation, and reduction in the duration and severity of upper respiratory tract infections in a pediatric population.

NCT04534036
Conditions
  1. Constipation
  2. Signs and Symptoms
  3. Digestive Signs and Symptoms
  4. Infrequent or Difficult Evacuation
Interventions
  1. Dietary Supplement: PDS-08
  2. Other: Placebo
MeSH:Constipation Signs and Symptoms, Digestive
HPO:Colonic inertia Constipation

Primary Outcomes

Description: Assessed as the change from baseline and compared to placebo for the continuous variable estimated using a linear mixed model.

Measure: Percentage of participants who are spontaneous bowel movement responders, defined as having an average of ≥ 4 complete spontaneous bowel movements (CSBMs) per week and an average increase of ≥ 1 CSBM from baseline, by age group: 3-6, 7-12, 13-17 years.

Time: Baseline-Day 84

Secondary Outcomes

Description: Assessed by daily stool characteristics reported using the seven-point ordinal BSFS score. The BSFS classifies human stool into seven types and scores them accordingly. Type 1: Separate hard lumps (hard to pass) Type 2: Sausage-shaped and lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage, smooth and soft Type 5: Soft blobs with clear cut edges (passed easily) Type 6: Fluffy pieces with ragged edges, a mushy stool Type 7: Watery, no solid pieces, entirely liquid. Types 1 and 2 indicate constipation, with 3 through 5 represent the ideal stool form, and 6 and 7 tend towards diarrhea. For a given assessment week, the weekly stool consistency is defined as the sum of non-missing stool consistency score for spontaneous bowel movements during that week divided by the number of non-missing stool consistency scores for spontaneous bowel movements during that week. The parameter will be analyzed using a linear mixed model.

Measure: Average increase from baseline of Bristol Stool Form Scale (BSFS) score by ≥ 1 point (stool characterized as an increase to either type 2 or 3 or 4) in the intervention group, compared to the placebo group.

Time: Baseline-Day 84

Measure: Decrease of ≥ 10% in time spent emptying bowel from beginning to end of bowel movement, compared to baseline.

Time: Baseline-Day 84

Description: Assessed by online daily symptom-tracking of stool-quality, regularity, ease of expulsion, bloating, and flatulence.

Measure: Changes in subjective assessment of gut tolerability as reported by parents or direct relative guardians, indicated by sustained (longer than 7 days of) abdominal pain, severe bloating, heartburn, acid reflux, or indigestion.

Time: Baseline-Day 84

Description: Microbiota composition will be identified through fecal samples for total genomic DNA extraction in participants supplemented with PDS-08 or placebo. Metagenomic sequencing will yield a total observable species count and maintenance will be defined as within 20% of the total observed species count when compared to baseline.

Measure: Maintenance or increase of diversity within the PDS-08 treatment group.

Time: Baseline-Day 84

Measure: Significant increase in QoL measured by the KINDL questionnaire with respect to mean change from baseline score (p<0.05).

Time: Baseline-Day 84

Measure: Exploratory: number of respiratory tract infections in the PDS-08 group compared to placebo.

Time: Baseline-Day 84

Measure: Exploratory: number and percent of participants with reduction in number of acne lesions from baseline as measured by global count of blemishes.

Time: Baseline-Day 84

Measure: Exploratory outcomes: changes in fecal calprotectin, histamine, bacterial enzymes (β-glucosidase and β-glucuronidase), β-defensin (hBD2) and short chain fatty acids in treatment group compared to the placebo group.

Time: Baseline-Day 84

HPO Nodes


HP:0002019: Constipation
Genes 484
CDKL5 TGIF1 MBD5 SH2B1 TCF4 ND6 TBL1X NODAL COL1A1 VPS35 DHCR7 GTF2IRD1 CAVIN1 COL7A1 APC SHH KIT TSHR NGLY1 ARVCF SIX3 SETD5 LAMA3 PPOX NR4A2 MRPS34 MED13 RORA PACS1 RREB1 MALT1 TTR SOX3 KDM1A ATXN8OS UBE3A CASR SCNN1G NKX2-5 NAB2 POLG LRRK2 FGF8 GAS1 PROKR2 GBA TGFBR2 PODXL FOXH1 IGH CLIP2 SCN10A VPS13C ELN RET CAMTA1 HIRA SPATA5 GP1BB SLC26A4 BRAF MEN1 COX1 ADNP DLL1 SEC24C TXNRD2 SIX3 FOXG1 POLG2 NKX2-5 ELN EXT2 PIK3CA TH TRH SCN11A TLK2 WAC SIK3 VPS11 PMS2 DUOXA2 FOXH1 P4HTM SOX10 IGHMBP2 CDON MLYCD MITF TTR MDH2 EDN3 PPOX HESX1 HESX1 KMT2A GAS1 PROP1 TRIO CREBBP TRNW MRAP HNRNPK KRT14 COL5A1 PCCA DACT1 FOXP1 KRAS CDON KCNJ1 VPS51 SHH DISP1 DDC CHST14 NKX2-1 KIT ZIC2 NFIX SLC12A3 THRA MADD SCN11A OCRL DISP1 SOX3 SLC25A4 KCNH1 KIT MED25 ALDOB FOXH1 TDGF1 FAN1 ADH1C SLC6A3 SEMA3D HPSE2 TRNS1 GLI2 POU1F1 FGF8 TRNH LHX4 PAX8 DEAF1 PPM1D ATXN2 FGFR1 STAR VANGL1 IYD DES NRXN1 TAF1 CACNA1S STXBP1 ND1 ARNT2 PAX8 ND4 FLI1 PCCB CHD8 FLNA ELP1 SCNN1A DISP1 ZEB2 STAG2 LMX1B ARID2 SIX3 TRNQ RAI1 LRIG2 PCCA MSH6 PDGFRA CHRM3 UNC80 RET TRNE ZIC2 MECP2 BCL10 SLC5A5 HMBS MSH2 CAMTA1 FGF8 SHH CREBBP TBCD NODAL SLC26A4 PTCH1 ZIC2 GALNT2 SDHA TRNF STAT6 CDC73 DLL1 RET PEX16 TRHR GJC2 SLC6A8 TRNS2 ODC1 FGFR1 DUOX2 MMP1 CDON LRIG2 GABRA3 PINK1 TSHR NNT OTUD6B CDKN1B TBCD WDR26 FOXG1 PTCH1 GATAD2B DNAJC6 UGP2 GLI2 SLC6A3 WAC TCF4 FDFT1 ALAD TSHB PRKN POLG2 GDNF DSE TCF20 SDHB CD96 FGFR1 SCN9A MC2R PCGF2 DNAJC13 COQ2 DDHD2 RPS20 LMNB1 OTX2 CAMK2B DDOST CDKN2C MED12 SMO ADAT3 SNCA CPOX APC2 MNX1 ASCL1 CNTNAP2 TNFRSF1A MAPT DHPS NSD1 SPOP RAI1 JMJD1C CREBBP COL7A1 GLI2 TRNK TBX1 NRXN1 SDHC ATRX EPCAM ZEB2 EDN3 UFC1 TBL2 TBX1 ABL1 ATRX SCN9A B2M WASF1 FOXA2 GRIN1 CSNK2A1 FOXP1 RFC2 LAMC2 LHX3 MADD PROP1 SNCA RRM2B LIMK1 HESX1 TWNK SIX3 EP300 SPART GLI2 NRTN PSMB8 EP300 PMS1 CDKN2B HTRA2 PROP1 POLG AVPR2 MAGEL2 ATN1 CDON ZMIZ1 HNRNPK EDNRB SOX10 AVPR2 IQSEC2 ATRX ECE1 CISD2 PRDM16 UBE3A DEAF1 ZIC2 AFF4 KRT5 GBA MLH1 FOXE1 EDN3 POGZ COX2 SLC6A8 PAX8 FOXH1 EXT2 TYMP PARK7 RAI1 SYNJ1 COX3 EIF4G1 PIGV LRRK2 FGF8 RERE POLG OTX2 TCF4 SLC12A3 TANC2 SKI TGIF1 WAC POGZ UNC80 HFE SMC1A TDGF1 CHST14 CLCNKB GIGYF2 PTCH1 LHX4 AQP2 PRNP WDR26 HMBS MEFV GLI2 GABRD SEMA4A SRCAP GLUD2 GAS1 GAS1 DMPK POU1F1 DYRK1A UFD1 COQ2 TGIF1 HNRNPH2 SCNN1B GTF2I TNFRSF1A MECP2 MEFV TSHR LAMB3 TG PTCH1 TDGF1 ZSWIM6 MSL3 UBE2A RAI1 BIRC3 MED12L HNRNPK TGIF1 BMPR1A ZEB2 PCCB SETD2 SOX2 NALCN OCRL OTUD6B CREBBP ALPL HIVEP2 TDGF1 PACS1 TRNL1 CDC73 DLL1 CHCHD2 SDHB SHH PHOX2B SLC5A5 CTNS SIX3 SNCAIP MLH3 ND5 STAG2 TBP ATRX AQP2 EP300 DDOST KCNJ18 MAGEL2 MLXIPL RET PAX8 PIGS TPO SLC12A1 WFS1 NODAL ACTG2 GDNF BAZ1B DLL1 VPS11 MED12 CDKN1A COMT USP7 EDNRB FLII SMPD1 COL5A2 NODAL KCNAB2 SDHC TRIO SALL1 DPF2 SEMA3C UCHL1 HPSE2 NALCN BRCA1 OCA2 DISP1 FGF12 TRNL1 UBE3B
Protein Mutations 2
G1314A G1321A
SNP 0
Protein Mutations 0
SNP 0

HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


HP:0002019: Constipation
Genes 484
CDKL5 TGIF1 MBD5 SH2B1 TCF4 ND6 TBL1X NODAL COL1A1 VPS35 DHCR7 GTF2IRD1 CAVIN1 COL7A1 APC SHH KIT TSHR NGLY1 ARVCF SIX3 SETD5 LAMA3 PPOX NR4A2 MRPS34 MED13 RORA PACS1 RREB1 MALT1 TTR SOX3 KDM1A ATXN8OS UBE3A CASR SCNN1G NKX2-5 NAB2 POLG LRRK2 FGF8 GAS1 PROKR2 GBA TGFBR2 PODXL FOXH1 IGH CLIP2 SCN10A VPS13C ELN RET CAMTA1 HIRA SPATA5 GP1BB SLC26A4 BRAF MEN1 COX1 ADNP DLL1 SEC24C TXNRD2 SIX3 FOXG1 POLG2 NKX2-5 ELN EXT2 PIK3CA TH TRH SCN11A TLK2 WAC SIK3 VPS11 PMS2 DUOXA2 FOXH1 P4HTM SOX10 IGHMBP2 CDON MLYCD MITF TTR MDH2 EDN3 PPOX HESX1 HESX1 KMT2A GAS1 PROP1 TRIO CREBBP TRNW MRAP HNRNPK KRT14 COL5A1 PCCA DACT1 FOXP1 KRAS CDON KCNJ1 VPS51 SHH DISP1 DDC CHST14 NKX2-1 KIT ZIC2 NFIX SLC12A3 THRA MADD SCN11A OCRL DISP1 SOX3 SLC25A4 KCNH1 KIT MED25 ALDOB FOXH1 TDGF1 FAN1 ADH1C SLC6A3 SEMA3D HPSE2 TRNS1 GLI2 POU1F1 FGF8 TRNH LHX4 PAX8 DEAF1 PPM1D ATXN2 FGFR1 STAR VANGL1 IYD DES NRXN1 TAF1 CACNA1S STXBP1 ND1 ARNT2 PAX8 ND4 FLI1 PCCB CHD8 FLNA ELP1 SCNN1A DISP1 ZEB2 STAG2 LMX1B ARID2 SIX3 TRNQ RAI1 LRIG2 PCCA MSH6 PDGFRA CHRM3 UNC80 RET TRNE ZIC2 MECP2 BCL10 SLC5A5 HMBS MSH2 CAMTA1 FGF8 SHH CREBBP TBCD NODAL SLC26A4 PTCH1 ZIC2 GALNT2 SDHA TRNF STAT6 CDC73 DLL1 RET PEX16 TRHR GJC2 SLC6A8 TRNS2 ODC1 FGFR1 DUOX2 MMP1 CDON LRIG2 GABRA3 PINK1 TSHR NNT OTUD6B CDKN1B TBCD WDR26 FOXG1 PTCH1 GATAD2B DNAJC6 UGP2 GLI2 SLC6A3 WAC TCF4 FDFT1 ALAD TSHB PRKN POLG2 GDNF DSE TCF20 SDHB CD96 FGFR1 SCN9A MC2R PCGF2 DNAJC13 COQ2 DDHD2 RPS20 LMNB1 OTX2 CAMK2B DDOST CDKN2C MED12 SMO ADAT3 SNCA CPOX APC2 MNX1 ASCL1 CNTNAP2 TNFRSF1A MAPT DHPS NSD1 SPOP RAI1 JMJD1C CREBBP COL7A1 GLI2 TRNK TBX1 NRXN1 SDHC ATRX EPCAM ZEB2 EDN3 UFC1 TBL2 TBX1 ABL1 ATRX SCN9A B2M WASF1 FOXA2 GRIN1 CSNK2A1 FOXP1 RFC2 LAMC2 LHX3 MADD PROP1 SNCA RRM2B LIMK1 HESX1 TWNK SIX3 EP300 SPART GLI2 NRTN PSMB8 EP300 PMS1 CDKN2B HTRA2 PROP1 POLG AVPR2 MAGEL2 ATN1 CDON ZMIZ1 HNRNPK EDNRB SOX10 AVPR2 IQSEC2 ATRX ECE1 CISD2 PRDM16 UBE3A DEAF1 ZIC2 AFF4 KRT5 GBA MLH1 FOXE1 EDN3 POGZ COX2 SLC6A8 PAX8 FOXH1 EXT2 TYMP PARK7 RAI1 SYNJ1 COX3 EIF4G1 PIGV LRRK2 FGF8 RERE POLG OTX2 TCF4 SLC12A3 TANC2 SKI TGIF1 WAC POGZ UNC80 HFE SMC1A TDGF1 CHST14 CLCNKB GIGYF2 PTCH1 LHX4 AQP2 PRNP WDR26 HMBS MEFV GLI2 GABRD SEMA4A SRCAP GLUD2 GAS1 GAS1 DMPK POU1F1 DYRK1A UFD1 COQ2 TGIF1 HNRNPH2 SCNN1B GTF2I TNFRSF1A MECP2 MEFV TSHR LAMB3 TG PTCH1 TDGF1 ZSWIM6 MSL3 UBE2A RAI1 BIRC3 MED12L HNRNPK TGIF1 BMPR1A ZEB2 PCCB SETD2 SOX2 NALCN OCRL OTUD6B CREBBP ALPL HIVEP2 TDGF1 PACS1 TRNL1 CDC73 DLL1 CHCHD2 SDHB SHH PHOX2B SLC5A5 CTNS SIX3 SNCAIP MLH3 ND5 STAG2 TBP ATRX AQP2 EP300 DDOST KCNJ18 MAGEL2 MLXIPL RET PAX8 PIGS TPO SLC12A1 WFS1 NODAL ACTG2 GDNF BAZ1B DLL1 VPS11 MED12 CDKN1A COMT USP7 EDNRB FLII SMPD1 COL5A2 NODAL KCNAB2 SDHC TRIO SALL1 DPF2 SEMA3C UCHL1 HPSE2 NALCN BRCA1 OCA2 DISP1 FGF12 TRNL1 UBE3B
Protein Mutations 2
G1314A G1321A
SNP 0
Protein Mutations 0
SNP 0

Reports

Data processed on December 13, 2020.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

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